Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9681146

FEI Number

3005430103

Entity Name

ZIEHM IMAGING GMBH

City/State/Country

NUERNBERG, BAVARIA, DE

Establishment Address

Lina-Ammon-Strasse 10, --, NUERNBERG, BAVARIA 90471, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ZIEHM IMAGING GMBH (Owner Number: 9019776)

Owner / Operator Contact Address

Lina-Ammon-Strasse 10, --, NUERNBERG, BAVARIA, DE-NOTA 90471, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K243646

PMA Number

N/A

All Registered Proprietary Names

Ziehm Vision RFD Ziehm Vision RFD 3D Ziehm Solo FD

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2025-02-28
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2025-02-28
OXO	Image-Intensified Fluoroscopic X-Ray System, Mobile	Radiology	Class 2	892.1650	2025-02-28
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2025-06-10
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2025-03-27
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2025-03-27
OXO	Image-Intensified Fluoroscopic X-Ray System, Mobile	Radiology	Class 2	892.1650	2025-03-27

Official Correspondent

Stefan Fiedler

US Agent Details

Kevin Bridgman Business: Ziehm-OrthoScan Inc. Email: kevin.bridgman@orthoscan.com Phone: (480) 7428453

Related Public Records

Same Entity

ZIEHM IMAGING GMBH

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
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
K024012	Ge Oec Medical Systems	OEC 9800 E/CV+ DIGITAL MOBILE IMAGING SYSTEM	2003-03-20
K970608	Guidant Cardiac and Vascular Surgery	EVT MARKER BOARD	1997-04-21

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;

Similar Registrations

Registration Number	Establishment Name	Location
3021027284	ANGIOWAVE IMAGING, INC.	Concord, MA, US
3042175844	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.	BEST Noord-Brabant, NL
3027373189	LIBERTY GLOBAL, LLC	Scottsdale, AZ, US
3033527282	Philips India Limited - Image Guided Therapy Systems Business Unit	Bengaluru Karnataka, IN
9614698	CANON INC.	OTAWARA-SHI Tochigi, JP

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9681146. Last updated year: 2026. Please use registration number 9681146 when referencing this establishment in official correspondence.