Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9616491

FEI Number

3000255482

Entity Name

APELEM

City/State/Country

Gallargues-le-Montueux Gard, FR

Establishment Address

9 Avenue du Canal Philippe LAMOUR, Gallargues-le-Montueux Gard 30660, FR

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

Apelem (Owner Number: 10047281)

Owner / Operator Contact Address

9 Avenue du Canal Philippe LAMOUR, Gallargues-le-Montueux, FR-30 30660, FR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K131766

PMA Number

N/A

All Registered Proprietary Names

Platinum dRF - version with RF4343FL PLATINUM dRF

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2016-12-15
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2014-08-01

Official Correspondent

Houda KACEM

US Agent Details

F. David Rothkopf Business: MEDIcept Email: drothkopf@medicept.com Phone: (617) 8993449

Related Public Records

Same Entity

Apelem

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
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
K203010	Apelem-Dms Group	Platinum dRF Imaging System	2021-01-22

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
1000221974	DMX IMAGING, LLC	Palm Harbor, FL, 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 9616491. Last updated year: 2026. Please use registration number 9616491 when referencing this establishment in official correspondence.