Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009607881

FEI Number

3009607881

Entity Name

QUALIFORMED SAS

City/State/Country

La Roche Sur Yon Pays de la Loire, FR

Establishment Address

19 impasse de La Boetie, La Roche Sur Yon Pays de la Loire 85000, FR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

QualiFormeD SAS (Owner Number: 10040700)

Owner / Operator Contact Address

19 impasse de La Boetie, La Roche Sur Yon, FR-PDL 85000, FR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

LINACWATCH OTP-FIELD OTP-LAS OTP-CROSS-KV2-VA OTP-PLATE-EL OTP-TOMOT-SR OTP-ABACUS-CL OTP-ALIGN OTP-PLAN OTP-FIELD-STICKER OTP-CROSS-MV OTP-ABACUS-EL OTP-FIELD28 OTP-BALL OTP-CROSS OTP-EPID-L OTP-ISO+ OTP-DISTO OTP-PLATE-VA OTP-TOMOT-ST OTP-EPID OTP-CROSS-KV2-EL OTP-FIELD03 OTP-FIELD18 OTP-FIELD08 MAGICTAPE FIELD-TAPE OTP-FIELD01 QUALIMAGIQ DIGIBOX QUALINAX DIGIPHAN OTP-CROSS-KV2-VA OTP-CROSS-MV OTP-FIELD28 OTP-ABACUS-EL OTP-PLATE-VA OTP-CROSS-KV2-EL OTP-DISTO OTP-ABACUS-CL OTP-PLATE-EL OTP-ALIGN OTP-LAS OTP-EPID OTP-TOMOT-ST OTP-TOMOT-SR OTP-CROSS OTP-EPID-L OTP-FIELD-STICKER OTP-BALL OTP-ISO+ OTP-FIELD OTP-PLAN OTP-FIELD08 OTP-FIELD01 MAGICTAPE OTP-FIELD03 OTP-FIELD18 FIELD-TAPE

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2017-12-22
IXF	Test-Pattern, Radiographic	Radiology	Class 1	892.1940	2012-07-11
LHO	Instrument, Quality-Assurance, Radiologic	Radiology	Class 1	892.1940	2012-05-09
IXG	Phantom, Anthropomorphic, Radiographic	Radiology	Class 1	892.1950	2012-05-09

Official Correspondent

Stephane Beaumont

US Agent Details

Maren Kroenke Business: Speed To Market, Inc. Email: mkroenke@speedtomarket.net Phone: (303) 9564233

Related Public Records

Same Entity

QualiFormeD SAS

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
K071992	Varian Medical Systems	HIGH-DEFINITION 120 MULTILEAF COLLIMATOR (HD120 MLC)	2007-08-15
K253962	Radformation, Inc.	ClearCheck (RADCC V2.7)	2026-04-03
K003779	Arplay Medical S.A.	IMMOBILIZATION SYSTEM FOR ENT	2001-07-12
K865100	Computerized Imaging Reference Systems, Inc.	TISSUE-EQUIVALENT BREAST SIMULATOR	1987-01-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0004-2019	Varian Medical Systems	2	TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
Z-0005-2019	Varian Medical Systems	2	VitalBeam Radiotherapy Delivery System Version 2.5 Product Usage: The VitalBeam delivery systems are intended to provide precision radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
Z-0020-2015	N/A	2	Proteus 235 Proton Therapy System for cancer treatment.
Z-0035-2012	Accuray Incorporated	2	CyberKnife Robotic Radiosurgery System, Synchrony Respiratory Tracking System (Standard Treatment Couch). Synchrony Respiratory Tracking System, a Radiation Therapy Device, Model Numbers: 026429, 028185. Product is manufactured and distributed by Accuray, Inc., Sunnyvale, CA
Z-0036-2012	Accuray Incorporated	2	CyberKnife Robotic Radiosurgery System, Synchrony Respiratory Tracking System (Robocouch Patient Positioning System), a Radiation Therapy Device. Model Numbers: 026430, 028186. Product is manufactured and distributed by Accuray, Inc., Sunnyvale, CA

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1722661	RADIOLOGICAL IMAGING TECHNOLOGY, INC.	Co Spgs, CO, US
3030077501	CHABNER XRT, LLC	Port Chester, NY, US
3007791541	Varian Medical Systems China Co., Ltd.	Beijing, CN
1932738	MEDTEC LLC	Orange City, IA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009607881. Last updated year: 2026. Please use registration number 3009607881 when referencing this establishment in official correspondence.