Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9610903

FEI Number

3002807145

Entity Name

PAUSCH Medical GmbH

City/State/Country

ERLANGEN Bavaria, DE

Establishment Address

GRAF-ZEPPELIN-STRASSE 1, ERLANGEN Bavaria 91056, DE

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

MAVIG GmbH (Owner Number: 9009516)

Owner / Operator Contact Address

Stahlgruberring 5, --, Munich, DE-BY 81829, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K161019

PMA Number

N/A

All Registered Proprietary Names

Pausch Radiologic table Uroview Fd Ii Pausch Diagnostic x-ray tube mount Uroview FD

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IXR	Table, Radiographic, Tilting	Radiology	Class 2	892.1980	2013-11-22
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2018-11-19
IYB	Tube Mount, X-Ray, Diagnostic	Radiology	Class 1	892.1770	2013-11-22
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2016-08-31

Official Correspondent

No official correspondent registered.

US Agent Details

Bill Titus Business: TI-BA Enterprises, Inc. Email: bill@ti-ba.com Phone: (585) 2471212

Related Public Records

Same Entity

MAVIG GmbH

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
9680506	MAVIG GMBH	MÜNCHEN Bavaria, DE

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K951176	Siemens Medical Solutions USA, Inc.	KOORDINAT M	1995-04-20
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-0001-2007	GE OEC Medical Systems, Inc	2	GE 4 inch Anterior Cervical Post, GE Part Number 1006385 or 1006385-NAV, GE Healthcare OEC Medical Systems (an accessory used with the InstaTrak 3500 plus and 9800 C-Arm Navigation systems)
Z-0001-2009	Philips Medical Systems North America Co. Phillips	2	NeuViz Dual Multi-Slice Computed Tomography (CT) Scanner System (software). Whole body x-ray computed tomography scanner which features a continuously rotating tube-detector system and functions according to the fan beam principle. The system software is an interactive program used for x-ray scan control, image reconstruction, and image archive/evaluation. It is intended to produce cross-section images of head and body by computer reconstruction of x-ray transmission data taken at different angles. The function of Time Scan is intended to use in contrast scan include single phase and multi-phase scan, that is according to different density of contrast in vessels or organs between different phase to get necessary information to support doctor's diagnosis.
Z-0004-2010	Ge Healthcare	2	GE OEC 9900 Elite ESP To produce mobile fluoroscopic images of human anatomy.
Z-0005-2010	Ge Healthcare	2	GE OEC 9900 Elite GSP Fluoroscopes To produce mobile fluoroscopic images of human anatomy.
Z-0009-04	Siemens Medical Solutions USA, Inc	2	Urology X-Ray System, Uroskop D1/D2/D3 - Hardware for Motor Drive

Similar Registrations

Registration Number	Establishment Name	Location
3012010520	MEDIFA GMBH	Finnentrop North Rhine-Westphalia, DE
3013846070	GREENS SURGICALS PRIVATE LIMITED	Vadodara Gujarat, IN
3008284470	GE Healthcare (China) Co., Ltd.	Beijing, CN
8030233	SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION	KYOTO, JP
3009077524	DHL SUPPLY CHAIN (NETHERLANDS) B.V.	Beringe Limburg, NL

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9610903. Last updated year: 2026. Please use registration number 9610903 when referencing this establishment in official correspondence.