Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9613152

FEI Number

3003772616

Entity Name

AGFA-GEVAERT HEALTHCARE GMBH

City/State/Country

PEISSENBERG Bavaria, DE

Establishment Address

MAX PLANCK STRASSE 1, PEISSENBERG Bavaria D82380, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Agfa N.V. (Owner Number: 10058267)

Owner / Operator Contact Address

Septestraat 27, Mortsel, BE-NOTA B-2640, BE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K092238

PMA Number

N/A

All Registered Proprietary Names

Drystar AXYS Crystal-M Imager Drystar AXYS XL DR 600 Pixium 4343 RCE Pixium 4343 RGE DR 600 FLFS Overlay NX 3 VALORY NX 3 NX 3 CR Advanced Reader CR Multi-Format Reader CR HD5S General Detector CR 15-X CR 12-X CR MD1 General Set CR 30-X CR MD4T FLFS Set NX 3 CR MD4T General Set DX-D Imaging Package DR 14s DR 10s NX 3 NX 3 Auto QC2 Mammography Crystal Imager Drystar 5302 CR MD4 General Set CR MD4 General Set SR CR 25 Digitizer CR MD4.1 FLFS Set NX 3 CR MM3 Extremities Set NX 3 CR MM3 Extremities Set CR MD4 General Set CR MD4.1 FLFS Set CR 85-X Radiology Diagnostic Kit 4343 C Radiology Diagnostic Kit 4343 R/F Radiology Diagnostic Kit 4343 G NX 4 DR 600 FLFS Overlay Pixium RAD 4343 NX 3 DR 600 MUSICA Engine CR 10-X CR Reader CR MD1 General Set CR MD4R General Set CR HD5 General Detector CR MD4 General Set HR CR HD5 AEC Detector CR MD4R FLFS Set CR MD4R General SR Set DX-G CR HD5 General SR Detector CR HD5 FLFS Detector NX 3 CR HD5 FLFS Cassette CR HD5 General Cassette

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LMC	Camera, Multi Format, Radiological	Radiology	Class 2	892.2040	2018-08-31
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2018-08-31
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2021-11-23
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2018-08-31
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2018-08-31
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2018-08-31
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2018-08-31
LHO	Instrument, Quality-Assurance, Radiologic	Radiology	Class 1	892.1940	2018-08-31
LMC	Camera, Multi Format, Radiological	Radiology	Class 2	892.2040	2018-08-31
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2018-08-31
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2018-08-31
OIP	Radiology-Diagnostic Kit	Radiology	Class 2	892.1680	2018-08-31
IZF	System, X-Ray, Tomographic	Radiology	Class 2	892.1740	2020-03-10
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2020-03-10
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2018-08-31
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2018-08-31

Official Correspondent

Koen Vervoort

US Agent Details

ShaeAnn Cavanagh Business: Agfa US Corp Email: shaeann.cavanagh@agfa.com Phone: (864) 3135016

Related Public Records

Same Entity

Agfa N.V.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3001556265	AGFA N.V.	Mortsel Antwerpen, BE

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

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.

Similar Registrations

Registration Number	Establishment Name	Location
3015276088	CAN TECHNOMED TRADING LTD.	Richmond British Columbia, CA
3001556265	AGFA N.V.	Mortsel Antwerpen, BE
1530958	CODONICS, INC.	Middleburg Heights, OH, US
3004977335	Siemens Healthineers AG	FORCHHEIM Bavaria, DE
3001722928	FUJIFILM CORPORATION	ASHIGARAKAMI-GUN Kanagawa, JP

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9613152. Last updated year: 2026. Please use registration number 9613152 when referencing this establishment in official correspondence.