Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004977335

FEI Number

3004977335

Entity Name

Siemens Healthineers AG

City/State/Country

FORCHHEIM Bavaria, DE

Establishment Address

SIEMENSSTRASSE 1 -OR-, Rittigfeld 1, FORCHHEIM Bavaria 91301, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Siemens Healthineers AG (Owner Number: 8010024)

Owner / Operator Contact Address

Karlheinz-Kaske-Str. 5, --, Erlangen, DE-NOTA 91052, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K201034

PMA Number

N/A

All Registered Proprietary Names

syngo. CT Vascular Analysis AI Rad Companion (Musculoskeletal) Somatom Perspective 16 & 32 slice config KENEX MOBILE CASSETT HOLDER (AS EXHIBIT #7) iterative Metal Artifact Reconstruction Software iMAR software syngo.CT Brain Hemorrhage syngo Virtual Cockpit (VB10A) syngo.CT Single Source Dual Energy (twin beam) VB20 Twin Beam SOMATOM X.ceed SOMATOM X.cite ARTIS ZEE / ZEEGO WITH SW VC14 AXIOM ARTIS - MODULAR ANGIOGRAPHIC SYSTEM syngo Aortic ValveGuide Software ARTIS icono (VE30A) X-Leonardo syngo.Interventional MAMMOMAT Revelation syngo Neuro PBV IR SOMATOM CT Systems with VC50 SW - SOMATOM Perspective, SOMATOM Scope/Scope Power and SOMATOM Emotion 16 syngo Carbon Enterprise Access (VA40A) SOMATOM Definition AS Open VA48 SOMATOM Definition AS Open SOMATOM Force SOMATOM Definition Confidence SOMATOM Definition AS/AS+ SOMATOM Definition Edge SOMATOM Definition AS Open SOMATOM Definition Flash SOMATOM Drive ARTIS genio floor (VE50B) ARTIS icono.explore floor (VE50B) Mammomat Fusion syngo.CT Colonography - Software Package with Extended Functionality Drystar AXYS syngo.CT Coronary Analysis syngo.CT Vascular Analysis Multitom Rax with True2scale Body Scan Option Ysio SYNGO VOLUME PERFUSION-CT NEURO SOMATOM DEFINITION, MODEL AS/AS+ SOMATOM Perspective (with syngo® CT VC30-easyIQ version) SOMATOM Perspective syngo Application Software VD11 Additional Pixium 2430 EZ-C ArtPix Mobile EZ2GO Additional Pixium 3543 EZ-C syngo.via RT Image Suite (VB70) syngo.MR General syngo.MR Vascular syngo.MR Cardiology AX WORKSTATION DR-VIEWER SOFTWARE OPTION SYNGO.MR SPECTRO ENGINE SYNGO.MR SPECTRO SVS SYNGO.MR SPECTRO CSI SYNGO.MR SPECTRO EXTENSION Cios Spin (VA30G) LUNGCARE CT SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY MODIFICATION TO SYNGO INSPACE 4D SOMATOM Force with SOMARIS/7 syngo CT VB30 SOMATOM Definition Edge with SOMARIS/7 syngo CT VB30 SOMATOM Edge Plus with SOMARIS/7 syngo CT VB30 SOMATOM Definition Flash with SOMARIS/7 syngo CT VB30 SOMATOM Definition AS/AS+ with SOMARIS/7 syngo CT VB30 SOMATOM Drive with SOMARIS/7 syngo CT VB30 SOMATOM Confidence with SOMARIS/7 syngo CT VB30 SOMATOM Definition AS Open with SOMARIS/7 syngo CT VB30 AZ-733 Respiratory Gatinn System ANZAI AZ-733 RESPIRATORY GATING SYSTEM syngo DynaPBV Body Software SOMATOM X.cite with SOMARIS/10 syngo CT VA 30 Scan&GO with SOMARIS/10 syngo CT VA 30 MODULAR ANGIOGRAPHY SYSTEM AXIOM ARTIS COLONGRAPHY SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY TOP ACOM STATION syngo.MR Neurology syngo Perfusion-CT INSPACE 4D SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY Inspace 4D syngo Application Software syngo.CT Cardiac Function UROSKOP OMNIA UROSKOP Omnia Max SOMATOM Definition AS Open MAMMOVISTA B.smart syngo Neuro DSA CT syngo.CT Dual Energy syngo.via RT Image Suite software version SOMARIS/8 VB50 Syngo Colonography syngo.CT LVO Detection (VB80) syngo expert I SOMATOM CARE CONTRAST CT syngo.CT Skull Unfolding syngo.Breast care AX Workstation syngo.via RT Image Suite syngo.CT Applications Dyna CT ARTIS pheno (VE50B) ARTIS icono Biplane (VE50B) ARTIS icono Floor (VE50B) ARTIS icono Ceiling (VE50B) syngo Dynamics Version VA30 syngo X-Workplace SW VD10 Syngo.CT Lung CAD syngo.CT Lung CAD (VD20) Multitom Rax ARTIS pheno Pulmo CT with Reference Database for the SOMATOM Plus and Plus 4 MOBILETTE XP AND MOBILETT XPHYBRID syngo.CT Neuro Perfusion Cios Alpha (VA30G) syngo Carbon Space (VA30A) MAMMOMAT INSPIRATION MODULARIS VARIOSTAR Somatom Definition AS Open (Somaris/7 VA46A) Somatom Force Arcadis Avantic YSIO X.pree (VA20) Luminos dRF Max Multitom Rax Uroskop Omnia Max Luminos Agile Max Luminos Lotus Max MAMMOMAT INSPIRATION PRIME MAMMOMAT 300 AND MAMMOMAT 3000 syngo.CT Extended Functionality syngo.CT Neuro Perfusion AI-Rad Companion (Pulmonary) MAMMOMAT Revelation (VC20) SOMATOM DEFINITION FLASH ARTIS pheno (VE30A) syngo.CT View&GO SYNGO, CT CARDIAC FUNCTION Arcadis Varic SIREMOBILE C06 syngo.CT Dual Energy (VB71) syngo.via (Version VB40A) ARTIS icono (VE23) MULTIX Impact E syngo application software version VD20 Multix Fusion Max SYNGO SINGLE SOURCE DUAL ENGERY FLUOROSPOT COMPACT SOMATOM Edge Plus SOMATOM go.Now SOMATOM go.Up SMB Family Opti Family Athlon Family RAY Family SIREPHOS Family OPTIPHOS Family Gigalix Family Megalix Cat Family S3P-Monoblock TR Family Megalix Family Megalix Cat Plus Family P40 MoW-100G Vectron Family CHRONON Family DURA Family Optilix Family STRATON Family Optitop Family Angiolux Family SOMATOM X.cite, with SOMARIS/10 syngo CT VA30 (Update) Scan&GO, with SOMARIS/10 syngo CT VA30 (Update) SOMATOM go.Up, with SOMARIS/10 syngo CT VA30 (Update) SOMATOM go.Top, with SOMARIS/10 syngo CT VA30 (Update) SOMATOM go. Open Pro, with SOMARIS/10 syngo CT VA30 (Update) SOMATOM go. Now, with SOMARIS/10 syngo CT VA30 (Update) SOMATOM go.All, with SOMARIS/10 syngo CT VA30 (Update) SOMATOM go.Sim, with SOMARIS/10 syngo CT VA30 (Update) Sensis Sensis Vibe syngo True D MULTIX Impact C syngo.CT Extended Functionality syngo.CT Brain Hemorrhage (VB80) ARTIS pheno (VE2) syngo.CT Lung CAD Mindray Patient Monitoring System SOMATOM go.Top with SOMARIS/10 syngo CT VB20 SOMATOM go.Now with SOMARIS/10 syngo CT VB20 SOMATOM go.Up with SOMARIS/10 syngo CT VB20 SOMATOM go.Sim with SOMARIS/10 syngo CT VB20 SOMATOM go.All with SOMARIS/10 syngo CT VB20 SOMATOM go.Open Pro with SOMARIS/10 syngo CT VB20 SOMATOM Pro.Pulse with SOMARIS/10 syngo CT VB20 syngo.CT Myocardial Perfusion Multix Fusion SOMATOM DEFINITION syngo.via VA20 (with Alpha Algorithm) syngo.CT CaScoring with software SOMARIS/8 VB40 syngo.CT Dual Energy syngo.CT Dual Energy (VB10) MULTIX Impact LEONARDO SYNGO CARDIOLOGY WORKSTATION SOMATOM RESPIRATORY GATING MAMMOREPORT SOFTCOPY WORKSTATION NAEOTOM Alpha, Scan&GO with SOMARIS/10 syngo CT VA50 Ysio Max Ysio Max Rad X-ray system (modular system of X-Ray) SOMATOM RADIATION TREATMENT PLANNING (RTP) PACKAGE syngo.via View&Go (VA40A) SOMATOM Definition Edge with SOMARIS/7 syngo CT VB20 SOMATOM Drive with SOMARIS/7 syngo CT VB20 SOMATOM Definition AS/AS+ with SOMARIS/7 syngo CT VB20 SOMATOM Confidence with SOMARIS/7 syngo CT VB20 SOMATOM Edge Plus with SOMARIS/7 syngo CT VB20 SOMATOM Definition AS Open with SOMARIS/7 syngo CT VB20 SOMATOM Definition Flash with SOMARIS/7 syngo CT VB20 SOMATOM Force with SOMARIS/7 syngo CT VB20 SOMATOM Emotion 6 syngo.MR Applications with new software version SMR VB40A syngo.MR Applications Cios Flow ARTIS Q MODULAR ANGIOGRAPHIC SYSTEM ARTIS Q.ZEN MODULAR ANGIOGRAPHIC SYSTEM Polydoros F / Polydoros R Family Polydoros A100 Family Polydoros RF Family Polydoros RFX Polydoros ACX syngo.via RT Image Suite ARCADIS ORBIC (AVAILABLE WITH OPTIONS 3D AND 3D NAVIGATION INTERFACE) Admire SOMATOM P47 SOMATOM Flash DS ARTIS pheno (VE21) syngo.CT Liver Analysis Siremobil Compact L Siremobil Compact ARTIS icono (VE21) SOMATOM Definition Flash with Stellar Detector Uroskop U04 endourological R/F system CALCIUM SCORING syngo Application Software (VD20) syngo.CT Dual Energy syngo Neuro PBV CT syngo.via RT Image Suite (VB80) IN SPACE 3D Ysio Max Artis DIGITAL IMAGING SYSTEM (BSR) Artis zee / zeego Artis Q and Artis Q.zen SOMATOM SENSATION 64 AND SENSATION CARDIAC AZ-733VI Respiratory Gating System NAEOTOM Alpha with SOMARIS/10 syngo CT VB10 Sliding Gantry Option for CT Devices syngo dual energy MODULTH SLK TILTING BUCKY TABLE POLYSTAR syngo mMR General SOMATOM On.site with software version SOMARIS/10 syngo CT VB10 MAMMOVISTA B.smart VB70 SYNGO, CT BONE READING syngo Application Software (VE40C) SOMATOM go.Now, with SOMARIS/10 syngo CT VA30 SOMATOM go.Open Pro, with SOMARIS/10 syngo CT VA30 SOMATOM go.Top, with SOMARIS/10 syngo CT VA30 SOMATOM go.Sim, with SOMARIS/10 syngo CT VA30 SOMATOM go.All, with SOMARIS/10 syngo CT VA30 SOMATOM go.Up, with SOMARIS/10 syngo CT VA30 Scan&Go, with SOMARIS/10 syngo CT VA30 syngo.via Webviewer Mobilett Impact ADMIRE Quantitative Dose Reduction ADMIRE ARTIS icono (VE2) System SOMATOM go.Open Pro with SOMARIS/10 syngo CT VB10 SOMATOM X.cite with SOMARIS/10 syngo CT VB10 SOMATOM X.ceed with SOMARIS/10 syngo CT VB10 SOMATOM go.Up with SOMARIS/10 syngo CT VB10 SOMATOM go.Top with SOMARIS/10 syngo CT VB10 SOMATOM go.All with SOMARIS/10 syngo CT VB10 SOMATOM go.Now with SOMARIS/10 syngo CT VB10 SOMATOM go.Sim with SOMARIS/10 syngo CT VB10 syngo.CT Single Source Dual Energy (twin beam) SOMATOM go.TOP SOMATOM go.All SOMATOM go.Up SOMATOM go.Now Scan&GO 3D CT Reconstruction Software LungCARE CT software package Multix Fusion Max w/SW VF10 syngo Application Software (VE30A) SOMATOM Definition Flash with SOMARIS/7 VA48 SOMATOM Definition Flash NAEOTOM Alpha.Pro with SW SOMARIS/10 syngo CT VB20 NAEOTOM Alpha.Prime with SW SOMARIS/10 syngo CT VB20 NAEOTOM Alpha/NAEOTOM Alpha.Peak with SW SOMARIS/10 syngo CT VB20 AXIOM SIRESKOP SD syngo.CT Dual Energy (VC10) Scan&Go AI-Rad Companion (Cardiovascular) SYNGO INSPACE 4D SOMATOM Confidence® RT Pro Multix Fusion VA30 and VA40 Multix Fusion syngo. plaza VB10A YSIO X.pree 3D-ANGIO SAFIRE AI-Rad Companion (Pulmonary) Cios Alpha Cios Alpha (SW VA30) SOMATOM P30 CT SYSTEMS ( Emotion MS- multislice) syngo.CT Neuro Perfusion Sensis Sensis Lite Cios Spin (VA31A) SYNGO CT ONCOLOGY SOFTWARE PACKAGE syngo Application Software syngo.CT Single Source Dual Energy (VB10) syngo.CT Single Source Dual Energy sungo.CT Pulmo 3D syngo.MR Applications (VB80) MAMMOMAT B.brilliant syngo.CT Applications SOMATOM Perspective SOMATOM Project P68 OPDIMA SOMATOM go.All with SOMARIS/10 syngo CT VA40 SOMATOM go.Up with SOMARIS/10 syngo CT VA40 SOMATOM go.Sim with SOMARIS/10 syngo CT VA40 SOMATOM X.cite with SOMARIS/10 syngo CT VA40 SOMATOM X.ceed with SOMARIS/10 syngo CT VA40 SOMATOM go.Top with SOMARIS/10 syngo CT VA40 SOMATOM go.Now with SOMARIS/10 syngo CT VA40 SOMATOM go.Open Pro with SOMARIS/10 syngo CT VA40 Scan&GO Software with SOMARIS/10 syngo CT VA40 syngo.RT Image Suite MULTIX Impact ARTIS ZEE/ZEEGO SW VC21 (with CARE claims) Low Dose Lung Cancer Screening for Siemens Computed Tomography (CT) Systems. SOMATOM Force Low Dose Lung Cancer Screening SOMATOM Definition Edge, SOMATOM Definition AS/AS+ FAST DE Results for Twin Beam Data post processing application for Definition AS/AS+ FAST DE Results for Twin Beam Data post processing application FAST DE Results for Twin Beam Data post processing application for Definition Edge syngo.CT CaScoring Mammomat Fusion with Stereotactic Biopsy syngo.MR General VB20 syngo.MR General Luminos dRF Max AXIOM LUMINOS DRF Mobilett Mira Max Mobilett Mira Cios Alpha Cios Flow Sensis NEWCOR CIARTIC Move (VB10) syngo.CT Extended Functionality syngo.via View&Go (VA30A) OSTEO CT FOR THE SOMATOM AR FAMILY AND PLUS 4 CT SYSTEMS SOMATOM Scope Power (with syngo® CT VC30-easyIQ version) SOMATOM Scope (with syngo® CT VC30- easyIQ version) Lithotriptor LITHOSKOP MR VB10 software upgrade syngo.MR Neurology syngo.MR Oncology syngo Application Software (VE51) YSIO X.pree Cios Spin (VA30) Cios Spin NAEOTOM Alpha.Prime with SOMARIS/10 syngo CT VB20 NAEOTOM Alpha.Peak with SOMARIS/10 syngo CT VB20 NAEOTOM Alpha with SOMARIS/10 syngo CT VB20 NAEOTOM Alpha.Pro with SOMARIS/10 syngo CT VB20 SYNGO CIRCULATION SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY syngo.CT CaScoring syngo.CT CaScoring SOMARIS/8 VB50

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2013-02-21
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2020-03-17
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2014-05-05
IXA	Cassette, Radiographic Film	Radiology	Class 2	892.1850	2018-06-15
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2015-01-19
QAS	Radiological Computer-Assisted Triage And Notification Software	Radiology	Class 2	892.2080	2022-02-01
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2023-12-26
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2023-12-26
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2023-12-26
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2017-02-10
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2026-03-23
IZI	System, X-Ray, Angiographic	Radiology	Class 2	892.1600	2014-11-23
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2011-04-19
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2011-04-19
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2013-02-25
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2013-02-25
IZI	System, X-Ray, Angiographic	Radiology	Class 2	892.1600	2023-12-15
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2023-12-15
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2023-12-15
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2023-12-15
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2011-04-19
MUE	Full Field Digital, System, X-Ray, Mammographic	Radiology	Class 2	892.1715	2018-03-22
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2013-12-16
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2019-04-17
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2019-04-17
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2024-05-31
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2015-05-14
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2018-04-18
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2026-04-24
IZI	System, X-Ray, Angiographic	Radiology	Class 2	892.1600	2026-04-24
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2026-04-24
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2026-04-24
MUE	Full Field Digital, System, X-Ray, Mammographic	Radiology	Class 2	892.1715	2015-09-15
NWE	Colon Computed Tomography System, Computer Aided Detection	Radiology	Class 2	892.2050	2014-12-15
LMC	Camera, Multi Format, Radiological	Radiology	Class 2	892.2040	2018-06-27
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2018-04-18
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2022-02-21
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2022-02-21
KPR	System, X-Ray, Stationary	Radiology	Class 2	892.1680	2013-05-16
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2013-02-25
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2013-02-20
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2016-03-28
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2016-03-04
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2018-06-27
KPR	System, X-Ray, Stationary	Radiology	Class 2	892.1680	2018-06-27
MUJ	System, Planning, Radiation Therapy Treatment	Radiology	Class 2	892.5050	2022-09-08
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2013-08-26
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2013-08-26
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2011-04-19
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2013-03-19
OXO	Image-Intensified Fluoroscopic X-Ray System, Mobile	Radiology	Class 2	892.1650	2021-02-23
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2021-02-23
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2021-02-23
OEB	Lung Computed Tomography System, Computer-Aided Detection	Radiology	Class 2	892.2050	2011-04-19
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2015-05-14
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2023-09-06
LHN	System, Radiation Therapy, Charged-Particle, Medical	Radiology	Class 2	892.5050	2018-07-15
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2013-03-14
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2019-11-21
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2009-03-09
IZI	System, X-Ray, Angiographic	Radiology	Class 2	892.1600	2009-03-09
NWE	Colon Computed Tomography System, Computer Aided Detection	Radiology	Class 2	892.2050	2011-04-19
IZI	System, X-Ray, Angiographic	Radiology	Class 2	892.1600	2011-04-19
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2013-03-25
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2011-04-19
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2015-02-16
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2018-03-22
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2013-09-03
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2010-08-06
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2010-08-06
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2013-03-07
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2021-11-15
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2013-03-06
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2022-03-30
MUJ	System, Planning, Radiation Therapy Treatment	Radiology	Class 2	892.5050	2020-08-14
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2011-04-19
QAS	Radiological Computer-Assisted Triage And Notification Software	Radiology	Class 2	892.2080	2025-04-11
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2011-04-19
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2011-04-19
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2021-07-26
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2013-03-14
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2011-04-19
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2015-08-14
MUJ	System, Planning, Radiation Therapy Treatment	Radiology	Class 2	892.5050	2015-08-14
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2024-01-05
IZI	System, X-Ray, Angiographic	Radiology	Class 2	892.1600	2011-04-19
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2026-04-27
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2026-04-27
IZI	System, X-Ray, Angiographic	Radiology	Class 2	892.1600	2026-04-27
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2026-04-27
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2017-06-12
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2015-03-05
OEB	Lung Computed Tomography System, Computer-Aided Detection	Radiology	Class 2	892.2050	2021-04-09
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2015-11-13
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2015-11-13
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2017-03-13
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2017-03-13
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2013-02-25
IZL	System, X-Ray, Mobile	Radiology	Class 2	892.1720	2008-01-21
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2013-09-03
OXO	Image-Intensified Fluoroscopic X-Ray System, Mobile	Radiology	Class 2	892.1650	2021-02-23
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2021-02-23
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2021-02-23
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2023-05-16
MUE	Full Field Digital, System, X-Ray, Mammographic	Radiology	Class 2	892.1715	2013-03-14
LNS	Lithotriptor, Extracorporeal Shock-Wave, Urological	Gastroenterology, Urology	Class 2	876.5990	2011-04-19
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2014-02-17
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2014-04-22
OXO	Image-Intensified Fluoroscopic X-Ray System, Mobile	Radiology	Class 2	892.1650	2005-09-12
KPR	System, X-Ray, Stationary	Radiology	Class 2	892.1680	2024-05-22
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2018-04-18
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2018-04-18
MUE	Full Field Digital, System, X-Ray, Mammographic	Radiology	Class 2	892.1715	2013-06-18
IZH	System, X-Ray, Mammographic	Radiology	Class 2	892.1710	2011-04-19
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2022-01-21
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2021-09-02
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2019-07-30
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2019-07-30
MUE	Full Field Digital, System, X-Ray, Mammographic	Radiology	Class 2	892.1715	2020-06-15
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2013-02-13
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2023-12-18
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2023-12-18
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2017-05-01
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2017-05-01
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2013-03-25
OXO	Image-Intensified Fluoroscopic X-Ray System, Mobile	Radiology	Class 2	892.1650	2009-02-09
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2009-02-09
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2023-12-01
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2019-09-05
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2022-07-20
IZI	System, X-Ray, Angiographic	Radiology	Class 2	892.1600	2022-07-20
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2022-07-20
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2022-07-20
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2022-05-18
KPR	System, X-Ray, Stationary	Radiology	Class 2	892.1680	2022-05-18
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2017-02-15
KPR	System, X-Ray, Stationary	Radiology	Class 2	892.1680	2016-11-23
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2013-03-26
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2011-04-19
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2018-05-09
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2017-03-28
ITY	Assembly, Tube Housing, X-Ray, Diagnostic	Radiology	Class 1	892.1760	2003-03-26
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2020-04-02
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2015-09-04
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2011-04-20
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2021-01-08
KPR	System, X-Ray, Stationary	Radiology	Class 2	892.1680	2021-01-08
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2023-05-30
QAS	Radiological Computer-Assisted Triage And Notification Software	Radiology	Class 2	892.2080	2024-03-26
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2020-06-30
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2020-06-30
OEB	Lung Computed Tomography System, Computer-Aided Detection	Radiology	Class 2	892.2050	2015-05-14
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2023-05-18
DSK	Computer, Blood-Pressure	Cardiovascular	Class 2	870.1110	2023-05-18
MLD	Monitor, St Segment With Alarm	Cardiovascular	Class 2	870.1025	2023-05-18
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2023-05-18
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2023-05-18
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	Class 2	870.1025	2023-05-18
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2023-05-18
DRT	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	Cardiovascular	Class 2	870.2300	2023-05-18
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2025-07-07
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2015-11-04
KPR	System, X-Ray, Stationary	Radiology	Class 2	892.1680	2013-02-26
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2011-04-19
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2013-09-24
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2019-12-17
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2015-08-13
KPR	System, X-Ray, Stationary	Radiology	Class 2	892.1680	2019-01-14
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2015-02-16
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2011-04-19
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2011-04-19
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2022-07-14
KPR	System, X-Ray, Stationary	Radiology	Class 2	892.1680	2014-02-18
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2011-04-19
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2023-02-21
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2019-12-04
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2011-04-19
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2020-02-03
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2020-02-03
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2021-01-04
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2021-01-04
OXO	Image-Intensified Fluoroscopic X-Ray System, Mobile	Radiology	Class 2	892.1650	2021-01-04
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2013-03-14
IZI	System, X-Ray, Angiographic	Radiology	Class 2	892.1600	2013-03-14
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2013-03-14
IZO	Generator, High-Voltage, X-Ray, Diagnostic	Radiology	Class 1	892.1700	2003-03-26
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2018-01-17
MUJ	System, Planning, Radiation Therapy Treatment	Radiology	Class 2	892.5050	2018-01-17
OXO	Image-Intensified Fluoroscopic X-Ray System, Mobile	Radiology	Class 2	892.1650	2009-07-28
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2009-07-28
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2009-07-28
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2014-06-24
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2013-02-25
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2022-07-01
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2022-07-01
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2014-12-02
OXO	Image-Intensified Fluoroscopic X-Ray System, Mobile	Radiology	Class 2	892.1650	2011-04-19
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2022-07-01
IZI	System, X-Ray, Angiographic	Radiology	Class 2	892.1600	2022-07-01
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2022-07-01
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2022-07-01
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2013-02-21
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2009-07-28
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2009-07-28
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2011-04-19
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2017-06-12
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2021-01-08
KPR	System, X-Ray, Stationary	Radiology	Class 2	892.1680	2021-01-08
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2021-09-02
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2013-03-06
MUJ	System, Planning, Radiation Therapy Treatment	Radiology	Class 2	892.5050	2024-04-29
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2011-04-19
KPR	System, X-Ray, Stationary	Radiology	Class 2	892.1680	2018-06-19
IZI	System, X-Ray, Angiographic	Radiology	Class 2	892.1600	2011-02-16
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2018-08-20
IZI	System, X-Ray, Angiographic	Radiology	Class 2	892.1600	2018-08-20
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2018-08-20
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2018-08-20
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2009-02-24
LHN	System, Radiation Therapy, Charged-Particle, Medical	Radiology	Class 2	892.5050	2018-04-17
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2024-04-01
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2011-04-19
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2011-04-19
LNS	Lithotriptor, Extracorporeal Shock-Wave, Urological	Gastroenterology, Urology	Class 2	876.5990	2019-02-22
IXR	Table, Radiographic, Tilting	Radiology	Class 2	892.1980	2003-03-26
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2014-07-18
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2014-07-18
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2024-09-04
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2023-01-27
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2013-03-25
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2024-10-15
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2019-12-04
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2014-07-18
IZL	System, X-Ray, Mobile	Radiology	Class 2	892.1720	2023-07-31
KPR	System, X-Ray, Stationary	Radiology	Class 2	892.1680	2023-07-31
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2016-06-29
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2020-04-17
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2020-04-17
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2020-04-17
IZI	System, X-Ray, Angiographic	Radiology	Class 2	892.1600	2020-04-17
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2024-03-27
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2016-02-22
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2018-05-17
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2011-04-19
KPR	System, X-Ray, Stationary	Radiology	Class 2	892.1680	2019-06-20
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2023-12-26
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2015-04-21
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2025-02-13
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2005-10-18
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2025-11-19
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2017-03-28
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2019-09-11
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2019-09-11
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2015-12-01
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2016-12-19
KPR	System, X-Ray, Stationary	Radiology	Class 2	892.1680	2015-01-07
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2014-02-18
KPR	System, X-Ray, Stationary	Radiology	Class 2	892.1680	2020-10-22
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2011-04-19
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2013-02-20
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2021-12-13
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2018-10-26
OXO	Image-Intensified Fluoroscopic X-Ray System, Mobile	Radiology	Class 2	892.1650	2018-10-26
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2011-04-19
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2017-03-02
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2013-09-17
OXO	Image-Intensified Fluoroscopic X-Ray System, Mobile	Radiology	Class 2	892.1650	2025-07-30
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2025-07-30
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2025-07-30
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2011-04-19
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2019-09-16
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2015-08-13
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2013-09-17
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2025-11-24
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2025-11-24
MUE	Full Field Digital, System, X-Ray, Mammographic	Radiology	Class 2	892.1715	2024-04-01
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2022-03-16
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2013-02-21
IZH	System, X-Ray, Mammographic	Radiology	Class 2	892.1710	2011-04-19
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2021-09-02
MUJ	System, Planning, Radiation Therapy Treatment	Radiology	Class 2	892.5050	2021-09-02
KPR	System, X-Ray, Stationary	Radiology	Class 2	892.1680	2020-03-23
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2014-09-09
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2014-09-09
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2014-09-09
IZI	System, X-Ray, Angiographic	Radiology	Class 2	892.1600	2014-09-09
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2015-12-01
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2015-11-03
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2023-05-30
MUE	Full Field Digital, System, X-Ray, Mammographic	Radiology	Class 2	892.1715	2017-01-11
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2017-02-07
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2017-02-07
OXO	Image-Intensified Fluoroscopic X-Ray System, Mobile	Radiology	Class 2	892.1650	2011-04-19
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2011-04-19
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2011-04-19
IZL	System, X-Ray, Mobile	Radiology	Class 2	892.1720	2013-03-28
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2025-07-10
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2025-07-10
OXO	Image-Intensified Fluoroscopic X-Ray System, Mobile	Radiology	Class 2	892.1650	2025-07-10
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2009-12-10
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2024-03-18
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2024-03-18
OXO	Image-Intensified Fluoroscopic X-Ray System, Mobile	Radiology	Class 2	892.1650	2024-03-18
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2021-09-02
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2022-10-20
KGI	Densitometer, Bone	Radiology	Class 2	892.1170	2011-04-19
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2011-04-19
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2016-03-22
LNS	Lithotriptor, Extracorporeal Shock-Wave, Urological	Gastroenterology, Urology	Class 2	876.5990	2009-07-28
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2015-08-11
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2015-08-11
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2026-04-30
KPR	System, X-Ray, Stationary	Radiology	Class 2	892.1680	2025-08-01
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2018-10-30
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2018-10-30
OXO	Image-Intensified Fluoroscopic X-Ray System, Mobile	Radiology	Class 2	892.1650	2018-10-30
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2025-07-30
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2015-05-14
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2020-05-18

Official Correspondent

No official correspondent registered.

US Agent Details

Robert Phillips Business: SIEMENS MEDICAL SOLUTIONS USA, INC. Email: robert.z.phillips@siemens-healthineers.com Phone: (302) 2359839

Related Public Records

Same Entity

Siemens Healthineers AG

View consolidated registration, premarket clearance, and recall records for this applicant.

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Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3000275399	Siemens Healthineers AG	RUDOLSTADT Thuringia, DE
3033524690	VUZE MEDICAL LTD.	TEL AVIV-JAFFA, IL
3011569702	SIEMENS X-RAY VACUUM TECHNOLOGY LTD.	Wuxi Jiangsu, CN
3002808157	Siemens Healthineers AG	ERLANGEN Bavaria, DE
3003202425	SIEMENS SHANGHAI, MEDICAL EQUIPMENT LTD.	SHANGHAI, CN

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K243523	Siemens Medical Solutions USA, Inc.	NAEOTOM Alpha.Peak/ NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime	2025-02-12
K781431	General Electric Co.	ELECTRIC CT/T OPERATOR DISPLAY CONSOLE	1978-09-07
K231574	FUJIFILM Healthcare Americas Corporation	Scenaria View 4.2	2023-10-12
K233583	FUJIFILM Healthcare Americas Corporation	FCT iSTREAM Phase 1	2024-04-26
K151376	Covidien, LLC	superDimension Navigation System	2015-11-05

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2011	GE Medical Systems, LLC	2	HiSpeed X/i Computed Tomography operator consoles with the Model Number 2153675 and 2247802. The expected usage of this product is to generate head and whole body CT images of human subjects.
Z-0009-2017	Philips Medical Systems	2	Brilliance 64 CT Model Number 728231 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Z-0010-2017	Philips Medical Systems	2	Ingenuity Core Model Number 728321 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Z-0011-2017	Philips Medical Systems	2	Ingenuity Core 128 Model Number 728323 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Z-0012-2017	Philips Medical Systems	2	Ingenuity CT Model Number 728326 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004977335. Last updated year: 2026. Please use registration number 3004977335 when referencing this establishment in official correspondence.