Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006542593

FEI Number

3006542593

Entity Name

OEHM UND REHBEIN GMBH

City/State/Country

ROSTOCK Mecklenburg-Western Pomerania, DE

Establishment Address

Neptunallee 7 c, ROSTOCK Mecklenburg-Western Pomerania 18057, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

OEHM UND REHBEIN GMBH (Owner Number: 9098601)

Owner / Operator Contact Address

Neptunallee 7 c, --, ROSTOCK, DE-MV 18057, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K141440

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2018-11-05
IZL	System, X-Ray, Mobile	Radiology	Class 2	892.1720	2018-11-05
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2007-06-05
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2013-11-22
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2013-11-22
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2014-12-11

Official Correspondent

Lena Schoenfeldt

US Agent Details

ALAN P. SCHWARTZ Business: MDI CONSULTANTS, INC. Email: alan@mdiconsultants.com Phone: (516) 4829001

Related Public Records

Same Entity

OEHM UND REHBEIN 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
K070563	Vidar Systems Corp.	VIDAR VISION 2000	2007-03-16
K190691	Pixxgen Corporation	Pixx2430 Digital Diagnostic X-Ray Receptor Panel	2019-04-04
K150150	Rayence Co., Ltd.	1717SGN / 1717SCN Digital Flat Panel X-ray Detector	2015-03-27
K140771	Philips Medical Systems Dmc GmbH	PHILIPS ELEVA WORKSPOT	2014-04-25
K153059	Minxray, Inc.	HF1202H PowerPlus Portable X-ray Equipment	2016-02-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0005-2009	Toshiba American Medical Systems Inc	2	Toshiba Infinix fluoroscopy DFP-8000D Digital Radiography System with version 3.40 or higher software. Controller for Infinix interventional angiography systems.
Z-0031-2007	AGFA Corp.	2	CR DX-S, Image Intensified Fluoroscopic X-ray system.
Z-1470-2023	FUJIFILM Healthcare Americas Corporation	2	FujiFilm FDR AQRO (Model DR-XD1000)- A digital mobile X-ray system intended for use in general purpose radiography for generating radiographic images of human anatomy, including adult, pediatric, and neonatal exams
Z-3158-2024	FUJIFILM Healthcare Americas Corporation	2	The device is a mobile x-ray system designed to work with Fujifilm's GOS and CsI scintillator FDR D-EVO2 (DR-ID) 12XXSE) family of digital x-ray detectors coupled.
Z-0012-2022	GE Healthcare, LLC	2	Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006542593. Last updated year: 2026. Please use registration number 3006542593 when referencing this establishment in official correspondence.