Siemens Healthineers AG

FDA Device Registration & Listing · KEMNATH Bavaria, DE · Registration 3002466018

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
3002466018
FEI Number
3002466018
Entity Name
Siemens Healthineers AG
City/State/Country
KEMNATH Bavaria, DE
Establishment Address
ROENTGENSTRASSE 19-21, KEMNATH Bavaria 95478, DE
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,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
K781984
PMA Number
N/A

All Registered Proprietary Names

Cios Spin (VA30G) Cios Spin (VA30) Cios Spin CIARTIC Move (VB10) Arcadis Avantic ARCADIS ORBIC (AVAILABLE WITH OPTIONS 3D AND 3D NAVIGATION INTERFACE) Bucky Wall Stand Family Cios Select (VA21) Image-Intensifier Siremobil Compact L Siremobil Compact Cios Flow Cios Connect Cios Select Cios Select VA10 Cios Alpha Cios Flow Cios Spin (VA31A) Arcadis Varic SIREMOBILE C06 Cios Alpha Cios Alpha (SW VA30) Cios Select Cios Select (VA20) Cios Alpha Cios Alpha VA20 Cios Alpha VA10 Cios Select (VA21) Flat Panel Collimator AIC Family Collimator RFU Family Collimator Angio Family Collimator N Family Collimator MFD Family Collimator LFD Family Collimator ML03 Collimator SFD Family Collimator N / N II Family Collimator CARD Family Collimator ML02 Family Collimator Mammo Family Collimator Mobile-C Family

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
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
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
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
OXO Image-Intensified Fluoroscopic X-Ray System, Mobile Radiology Class 2 892.1650 2005-09-12
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
IXY Holder, Radiographic Cassette, Wall-Mounted Radiology Class 1 892.1880 2014-07-07
OXO Image-Intensified Fluoroscopic X-Ray System, Mobile Radiology Class 2 892.1650 2021-03-08
OWB Interventional Fluoroscopic X-Ray System Radiology Class 2 892.1650 2021-03-08
JAA System, X-Ray, Fluoroscopic, Image-Intensified Radiology Class 2 892.1650 2021-03-08
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 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
OXO Image-Intensified Fluoroscopic X-Ray System, Mobile Radiology Class 2 892.1650 2016-01-13
OWB Interventional Fluoroscopic X-Ray System Radiology Class 2 892.1650 2016-01-13
JAA System, X-Ray, Fluoroscopic, Image-Intensified Radiology Class 2 892.1650 2016-01-13
OXO Image-Intensified Fluoroscopic X-Ray System, Mobile Radiology Class 2 892.1650 2016-02-11
JAA System, X-Ray, Fluoroscopic, Image-Intensified Radiology Class 2 892.1650 2016-02-11
OWB Interventional Fluoroscopic X-Ray System Radiology Class 2 892.1650 2016-02-11
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
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
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
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
OWB Interventional Fluoroscopic X-Ray System Radiology Class 2 892.1650 2018-08-20
JAA System, X-Ray, Fluoroscopic, Image-Intensified Radiology Class 2 892.1650 2018-08-20
OXO Image-Intensified Fluoroscopic X-Ray System, Mobile Radiology Class 2 892.1650 2018-08-20
OWB Interventional Fluoroscopic X-Ray System Radiology Class 2 892.1650 2014-03-13
OXO Image-Intensified Fluoroscopic X-Ray System, Mobile Radiology Class 2 892.1650 2014-03-13
OXO Image-Intensified Fluoroscopic X-Ray System, Mobile Radiology Class 2 892.1650 2021-03-08
OWB Interventional Fluoroscopic X-Ray System Radiology Class 2 892.1650 2021-03-08
JAA System, X-Ray, Fluoroscopic, Image-Intensified Radiology Class 2 892.1650 2021-03-08
KPW Device, Beam Limiting, X-Ray, Diagnostic Radiology Class 2 892.1610 2009-04-28

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.
View Entity Profile →

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
3004977335 Siemens Healthineers AG FORCHHEIM Bavaria, DE

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K060344 Breakaway Imaging, LLC O-ARM IMAGING SYSTEM 2006-03-29
K982706 Philips Medical Systems, Inc. PHILIPS BV300 SERIES RELEASE 2.1 1998-09-02
K163715 Philips Medical Systems Nederland B.V. Allura Xper R9 2017-01-26
K863853 Superior Medical Products EAZY COVERS 1987-03-06
K953974 Medivision Medical Imaging, Ltd. CAMVISION 1000 1996-09-09

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0001-2026 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands 2
Allura Xper FD10C; Model Number: 722001; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Z-0002-2026 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands 2
Allura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Z-0003-2026 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands 2
Allura Xper FD10/10; Model Numbers: (1) 722005, (2) 722011, (3) 722027; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Z-0004-2026 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands 2
Allura Xper FD10 OR Table; Model Numbers: 722033; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Z-0005-2026 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands 2
Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3002466018. Last updated year: 2026. Please use registration number 3002466018 when referencing this establishment in official correspondence.
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