Siemens Healthineers AG

FDA Device Registration & Listing · ERLANGEN Bavaria, DE · Registration 3002808157

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3002808157
FEI Number
3002808157
Entity Name
Siemens Healthineers AG
City/State/Country
ERLANGEN Bavaria, DE
Establishment Address
Allee am Rothelheimpark 2, ERLANGEN Bavaria 91052, 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
N
Expiration Date (Year)
2026
510(k) Number
K190757
PMA Number
N/A

All Registered Proprietary Names

syngo Dynamics (VA41D) syngo.MR General VB20 syngo.MR General SYNGO MR B17 MAGNETOM Terra (syngo MR E12U) MAGNETOM Terra AI-Rad Companion (Pulmonary) VA40 syngo.via VA20 (without Alpha Algorithm) Noras - OR HEAD COIL 1.5 T MAGNETOM Terra AI-Rad Companion (Pulmonary) VA20 Biograph mMR VB20P Software syngo MR B20P for Biograph mMR CLINICAL PHOSPHORUS SPECTROSCOPY OPTION/MAGNETOM VISION SYSTEM MAGNETOM Skyra with Software syngo MR E11E with Ischemic Heart Disease (IHD) Workflow MAGNETOM Aera with Software syngo MR E11E with Ischemic Heart Disease (IHD) Workflow MAGNETOM TRIO A TIM SYSTEM AI-Rad Companion Organs RT (VA40) MAGNETOM Free.Max MAGNETOM Skyra Fit with syngo MR XA50A ACTIVE ECG ELECTRODES MAGNETOM VISION SYSTEMS 5MP Monochrome LCD Monitor, RadiForce GX540 syngo MR E11C software for MAGNETOM Avantofit MR Systems syngo MR E11C software for MAGNETOM Skyrafit MR Systems MAGNETOM Free.Star XA80A MAGNETOM Free.Max Chondral Quant 6 CHANNEL BODY COIL MAGNETOM Trio MAGNETOM Systems with SW syngo MR 2006A (SW VB13) MAGNETOM Symphony MAGNETOM Espree MAGNETOM Avanto Chapot Table System syngo BreVis Biopsy MRWP # Tim syngo BreVis MRWP # Tim MAGNETOM VIDA MAGNETOM Lumina MAGNETOM Lumina (syngo MR XA11B) syngo.MR Applications with new software version SMR VB40A syngo.MR Applications MAGNETOM Sempra MAGNETOM Amira MAGNETOM Skyra with syngo MR D11 MAGNETOM Aera with syngo MR D11 AI-Rad Companion Prostate MR (VA60) AI-Rad Companion Brain MR (VA60) BREAST BIOPSY DEVICE/MAGNETOM SYSTEMS MAGNETOM Aera with syngo SW XA30A MAGNETOM Skyra with syngo SW XA30A MAGNETOM Prisma/ Prismafit with syngo SW XA30A MAGNETOM Amira with software syngo MR E11S syngo.MR Oncology MAGNETOM Altea MAGNETOM Sola MAGNETOM Sola w/syngo MR XA11A MAGNETOM Altea with SW syngo MR XA11B CP BREAST ARRAY COIL/MAGNETOM HARMONY/SYMPHONY SYSTEM AI-Rad Companion Prostate MR Tim TX TrueShape and VD13C for MAGNETOM Skyra CP PERIPHERAL ANGIO ARRAY COIL/ MAGNETOM SYMPHONY SYSTEM MAGNETOM Skyra Fit MAGNETOM Sola Fit MAGNETOM Viato.Mobile XA70A MAGNETOM Avanto Fit MRI SOFT TISSUE MOTION CORRECTION SOFTWARE VA10A NORAS Surgery Head Coil, Set, 3T OR 8-channel coil #Es NORAS Head Coil-Bottom Half Only Noras OR Head Holder + Coil Set 3T OR Head Coil 3T MAGNETOM Altea with syngo MR XA61A MAGNETOM Sola with syngo MR XA61A Biograph mMR MAGNETOM Sola w/XJ gradient system MAGNETOM SOLA MAGNETOM Terra with syngo MR XA60A MAGNETOM Terra.X (7T) with syngo MR XA60A MAGNETOM Sempra (syngo MR XA12M) MAGNETOM Amira (syngo MR XA12M) MAGNETOM Mica MR VB10 software upgrade syngo.MR Neurology syngo.MR Oncology MAGNETOM Vida with syngo MR XA50A MAGNEITOM Systems I -class and] T-class releases syngo MR BI 5 MAGNETOM Vida MAGNETOM Lumina MAGNETOM Vida Fit MAGNETOM AVANTO MR SYSTEM MAGNETIC CONCERTO MAGNETOM Sola with syngo MR XA51A MAGNETOM Sola Fit with syngo MR XA51A MAGNETOM Altea with syngo MR XA51A syngo.mMR General syngo.MR Neurology syngo.MR BreVis syngo.MR Oncology MAGNETOM Avantofit with syngo MR E11C-AP04 SW MAGNETOM Prismafit with syngo MR E11C-AP04 SW MAGNETOM Aera with syngo MR E11C-AP04 SW MAGNETOM Skyra with syngo MR E11C-AP04 SW MAGNETOM Prisma with syngo MR E11C-AP04 SW MAGNETOM Skyrafit with syngo MR E11C-AP04 SW MAGNETOM Artis Combi Suite MAGNETOM SYMPHONY A TIM SYSTEM MAGNETOM Flow.Elite MAGNETOM Vida Fit MAGNETOM Vida MAGNETOM Flow.Rise MAGNETOM Viato.Mobile MAGNETOM Lumina Syngo MR XB10A MAGNETOM Sola MAGNETOM Altea MAGNETOM Flow.Neo MAGNETOM Sola Fit AI-Rad Companion Organs RT (VA20) MAGNETOM Skyra Fit MAGNETOM Avanto Fit AI-Rad Companion Organs RT (VA70A) Innovision Audio Biograph mMR with mMR Angio Transfer Option AI-Rad Companion (Cardiovascular) VA20 MAGNETOM ESSENZA WITH SYNGO MR D14 syngo mMR General CP FLEXIBLE COILS/ LP CIRCULAR FLEX COILS Stationary X-Ray Grid Magnetom Prisma Magnetom Prisma fit AI-Rad Companion Brain MR VA20 CORDLESS COIL - Magnetom MAGNETOM ESPREE SYSTEM OR TABLE AND HEADHOLDER/MAGNETOM HARMONY, SYMPHONY, SONATA SYSTEMS MAGNETOM Viato.Mobile with syngo MR XA51A with XQ Gradient MAGNETOM Vida with Nexaris Angio-MR MAGNETOM Sola with Nexaris Angio-MR syngo MR XA10A BIOGRAPH One MAGNETOM Verio MR E11D MAGNETOM Verio w/syngo MR E11D MAGNETOM Avanto MR E11D MAGNETOM Avanto MAGNETOM Avanto w/syngo MR E11D MAGNETOM Verio NUMARIS 4VA15A software MAGNETOM Vida with Compressed Sensing GRASP-VIBE AI-Rad Companion Engine 31P/1H HEADCOIL FOR MAGNETOM ALLEGRA syngo.MR Applications syngo.MR Brain MAGNETOM Cima.X syngo MR E11Q syngo MR E11Q SW for the MAGNETOM ESSENZA SONATA GRADIENTS/MAGNETOM SYMPHONY SYSTEM MAGNETOM Skyra MAGNETOM Aera MAGNETOM Aera (MR E11C-AP01) MAGNETOM Aera MAGNETIC RESON DIAG DEVICE MAGNETOM PROJECT 016 FUNCTIONAL MRI PACKAGE FOR MAGETETOM VISION MR Syngo MR E11 Syngo MR E11 for MAGNETOM Aera (24) (1.5T), MAGNETOM Avantofit (1.5T), MAGNETOM Skyrafit (3T) and MAGNETOM Prisma/Prismafit (3T) syngo.MR Neurology MAGNETOM Vida VA10A LungMaps MAGNETOM Aera - Mobile Solution with Tim Dockable Table AI-Rad Companion Brain MR VA40 MAGNETOM Lumina with syngo MR XA50A MAGNETOM Vida Fit with syngo MR XA50A AI-Rad Companion Organs RT (VA60) syngo.MR General syngo.MR Vascular syngo.MR Cardiology AI-Rad Companion (Musculoskeletal) VA20 syngo.MR Applications Software syngo MR B19 for MAGNETOM Symphony A Tim System Software syngo MR B19 for MAGNETOM Espree Software syngo MR B19 for MAGNETOM Trio A Tim System Software syngo MR B19 for MAGNETOM Verio Software syngo MR B19 for MAGNETOM Avanto MAGNETOM Viato.Mobile MAGNETOM SYSTEMS WITH SYNGO EXPERT - I OPTION Biograph mMR with syngo MR E11P System software MAGNETOM Avanto Fit with syngo MR XA50A SOFTWARE SYNGO MR D13A FOR THE MAGNETOM SYSTEMS AERA/SKYRA/AVANTO/ VERIO MAGNETOM PROJECT 047 SYSTEM (NUMARIS 3.5 SOFTWARE) MAGNETOM Aera with syngo MR D13E MAGNETOM Aera 1.5T System MAGNETOM Avantofit with SW syngo VE11E

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
QIH Automated Radiological Image Processing Software Radiology Class 2 892.2050 2025-11-19
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
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2015-02-16
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2019-02-17
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2019-02-17
LNI System, Nuclear Magnetic Resonance Spectroscopic Radiology Class 2 892.1000 2019-02-17
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2024-04-01
QIH Automated Radiological Image Processing Software Radiology Class 2 892.2050 2024-04-01
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2014-12-01
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2011-04-20
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2017-10-24
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2022-08-31
QIH Automated Radiological Image Processing Software Radiology Class 2 892.2050 2022-08-31
OUO Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance Radiology Class 2 892.1200 2013-12-16
LNI System, Nuclear Magnetic Resonance Spectroscopic Radiology Class 2 892.1000 2010-03-22
LNI System, Nuclear Magnetic Resonance Spectroscopic Radiology Class 2 892.1000 2019-07-12
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2019-07-12
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2019-07-12
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2011-04-20
QKB Radiological Image Processing Software For Radiation Therapy Radiology Class 2 892.2050 2022-10-20
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2021-07-02
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2021-07-02
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2022-05-17
LNI System, Nuclear Magnetic Resonance Spectroscopic Radiology Class 2 892.1000 2022-05-17
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2022-05-17
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2011-04-20
PGY Display, Diagnostic Radiology Radiology Class 2 892.2050 2018-07-18
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2016-11-23
LNI System, Nuclear Magnetic Resonance Spectroscopic Radiology Class 2 892.1000 2016-11-23
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2016-11-23
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2025-11-24
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2025-11-24
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2023-07-14
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2023-07-14
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2011-04-20
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2015-02-16
FOX Stand, Infusion General Hospital Class 1 880.6990 2020-04-29
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2014-01-10
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2018-10-22
LNI System, Nuclear Magnetic Resonance Spectroscopic Radiology Class 2 892.1000 2018-10-22
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2018-10-22
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2019-01-25
LNI System, Nuclear Magnetic Resonance Spectroscopic Radiology Class 2 892.1000 2019-01-25
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2019-01-25
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
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2023-04-17
LNI System, Nuclear Magnetic Resonance Spectroscopic Radiology Class 2 892.1000 2023-04-17
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2023-04-17
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2013-03-26
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2025-09-26
QIH Automated Radiological Image Processing Software Radiology Class 2 892.2050 2026-02-03
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2011-04-20
LNI System, Nuclear Magnetic Resonance Spectroscopic Radiology Class 2 892.1000 2020-09-11
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2020-09-11
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2020-09-11
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2018-01-02
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2018-01-02
LNI System, Nuclear Magnetic Resonance Spectroscopic Radiology Class 2 892.1000 2018-01-02
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2013-03-27
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2018-10-30
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2018-10-30
LNI System, Nuclear Magnetic Resonance Spectroscopic Radiology Class 2 892.1000 2018-10-30
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2011-04-20
QIH Automated Radiological Image Processing Software Radiology Class 2 892.2050 2020-12-09
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2020-12-09
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2013-05-21
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2011-04-20
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2025-06-17
LNI System, Nuclear Magnetic Resonance Spectroscopic Radiology Class 2 892.1000 2025-06-17
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2025-06-17
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2012-09-17
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2018-07-05
LNI System, Nuclear Magnetic Resonance Spectroscopic Radiology Class 2 892.1000 2023-12-26
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2023-12-26
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2023-12-26
OUO Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance Radiology Class 2 892.1200 2011-06-23
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2018-10-22
LNI System, Nuclear Magnetic Resonance Spectroscopic Radiology Class 2 892.1000 2018-10-22
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2024-03-25
LNI System, Nuclear Magnetic Resonance Spectroscopic Radiology Class 2 892.1000 2024-03-25
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2024-03-25
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2019-02-15
LNI System, Nuclear Magnetic Resonance Spectroscopic Radiology Class 2 892.1000 2019-02-15
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2019-02-15
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
LNI System, Nuclear Magnetic Resonance Spectroscopic Radiology Class 2 892.1000 2022-03-01
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2022-03-01
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2022-03-01
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2015-01-23
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2020-03-17
LNI System, Nuclear Magnetic Resonance Spectroscopic Radiology Class 2 892.1000 2020-03-17
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2020-03-17
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2011-02-16
LNI System, Nuclear Magnetic Resonance Spectroscopic Radiology Class 2 892.1000 2011-02-16
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2015-02-13
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2022-09-15
LNI System, Nuclear Magnetic Resonance Spectroscopic Radiology Class 2 892.1000 2022-09-15
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2022-09-15
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2014-03-13
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2014-03-13
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2018-02-15
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2018-02-15
LNI System, Nuclear Magnetic Resonance Spectroscopic Radiology Class 2 892.1000 2018-02-15
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2014-04-10
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2011-02-16
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2025-12-26
LNI System, Nuclear Magnetic Resonance Spectroscopic Radiology Class 2 892.1000 2025-12-26
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2025-12-26
QKB Radiological Image Processing Software For Radiation Therapy Radiology Class 2 892.2050 2020-12-11
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2013-05-21
QKB Radiological Image Processing Software For Radiation Therapy Radiology Class 2 892.2050 2026-04-20
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2022-02-04
LNI System, Nuclear Magnetic Resonance Spectroscopic Radiology Class 2 892.1000 2017-11-17
OUO Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance Radiology Class 2 892.1200 2017-11-17
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2017-11-17
KPS System, Tomography, Computed, Emission Radiology Class 2 892.1200 2017-11-17
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2024-02-02
QIH Automated Radiological Image Processing Software Radiology Class 2 892.2050 2024-02-02
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2013-03-26
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
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2011-04-20
IXJ Grid, Radiographic Radiology Class 1 892.1910 2017-06-19
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2013-12-16
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2020-07-07
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2011-04-20
LNI System, Nuclear Magnetic Resonance Spectroscopic Radiology Class 2 892.1000 2009-02-20
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2009-02-20
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2011-04-20
LNI System, Nuclear Magnetic Resonance Spectroscopic Radiology Class 2 892.1000 2024-04-01
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2024-04-01
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2024-04-01
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2022-03-15
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2026-01-19
LNI System, Nuclear Magnetic Resonance Spectroscopic Radiology Class 2 892.1000 2026-01-19
OUO Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance Radiology Class 2 892.1200 2026-01-19
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2026-01-19
KPS System, Tomography, Computed, Emission Radiology Class 2 892.1200 2026-01-19
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2018-11-07
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2018-11-07
LNI System, Nuclear Magnetic Resonance Spectroscopic Radiology Class 2 892.1000 2018-11-07
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2015-02-13
LNI System, Nuclear Magnetic Resonance Spectroscopic Radiology Class 2 892.1000 2018-05-09
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2018-05-09
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2020-12-11
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2011-04-20
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2019-07-08
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2019-07-08
LNI System, Nuclear Magnetic Resonance Spectroscopic Radiology Class 2 892.1000 2023-12-20
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2023-12-20
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2023-12-20
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2016-11-21
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2016-11-21
LNI System, Nuclear Magnetic Resonance Spectroscopic Radiology Class 2 892.1000 2016-11-21
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2011-02-16
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2011-03-03
LNI System, Nuclear Magnetic Resonance Spectroscopic Radiology Class 2 892.1000 2018-10-26
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2018-10-26
MOH Monitor, Heart Rate, Fetal, Non-Stress Test (Home Use) Obstetrics/Gynecology Class 2 884.2730 2018-10-26
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2011-02-16
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2011-04-20
LNI System, Nuclear Magnetic Resonance Spectroscopic Radiology Class 2 892.1000 2015-10-01
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2015-10-01
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2015-10-01
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2013-03-25
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2023-02-27
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2023-02-27
LNI System, Nuclear Magnetic Resonance Spectroscopic Radiology Class 2 892.1000 2023-02-27
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2026-06-18
QIH Automated Radiological Image Processing Software Radiology Class 2 892.2050 2026-06-18
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2019-02-18
LNI System, Nuclear Magnetic Resonance Spectroscopic Radiology Class 2 892.1000 2019-02-18
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2019-02-18
QIH Automated Radiological Image Processing Software Radiology Class 2 892.2050 2022-04-22
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2022-05-03
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2022-05-03
LNI System, Nuclear Magnetic Resonance Spectroscopic Radiology Class 2 892.1000 2022-05-03
QKB Radiological Image Processing Software For Radiation Therapy Radiology Class 2 892.2050 2025-04-10
MUJ System, Planning, Radiation Therapy Treatment Radiology Class 2 892.5050 2025-04-10
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
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2022-11-04
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2018-04-24
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2018-04-24
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2013-03-27
LNI System, Nuclear Magnetic Resonance Spectroscopic Radiology Class 2 892.1000 2023-09-08
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2023-09-08
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2023-09-08
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2011-04-20
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2017-03-01
KPS System, Tomography, Computed, Emission Radiology Class 2 892.1200 2017-03-01
OUO Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance Radiology Class 2 892.1200 2017-03-01
LNI System, Nuclear Magnetic Resonance Spectroscopic Radiology Class 2 892.1000 2017-03-01
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2022-04-04
LNI System, Nuclear Magnetic Resonance Spectroscopic Radiology Class 2 892.1000 2022-04-04
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2022-04-04
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2013-03-19
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2013-03-19
LNI System, Nuclear Magnetic Resonance Spectroscopic Radiology Class 2 892.1000 2013-03-19
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2011-02-16
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2013-12-16
LNI System, Nuclear Magnetic Resonance Spectroscopic Radiology Class 2 892.1000 2019-06-03
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2019-06-03
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2019-06-03

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) 6319702

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Siemens Healthineers AG
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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
3004977335 Siemens Healthineers AG FORCHHEIM Bavaria, DE
3003202425 SIEMENS SHANGHAI, MEDICAL EQUIPMENT LTD. SHANGHAI, CN

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Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system
Z-0023-2016 GE Healthcare 2
Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.
Z-0030-2026 CHANGE HEALTHCARE CANADA COMPANY 2
Change Healthcare Radiology Solutions software version 14.2.2
Z-0032-2012 Philips Healthcare Inc. 2
MDC PACS - release R2.3 SP1 . Phillips Healthcare Andover, Massachusetts A software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD).
Z-0033-2007 AGFA Corp. 2
IMPAX 5.2 Systems with CAD Capability (Computer Assisted Diagnosis)

Similar Registrations

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3042852277 REMEDY LOGIC New York, NY, US
3027986210 MRIGUIDANCE B.V. Utrecht, NL
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3002808157. Last updated year: 2026. Please use registration number 3002808157 when referencing this establishment in official correspondence.
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