Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9710332

FEI Number

3003251135

Entity Name

3C-Medical Intelligence GmbH

City/State/Country

Landsberg am Lech Bavaria, DE

Establishment Address

3C-Ring 1, Landsberg am Lech Bavaria 86899, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

3C-Medical Intelligence GmbH (Owner Number: 10082856)

Owner / Operator Contact Address

3C-Ring 1, Landsberg am Lech, DE-BY 86899, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

HexaPOD BodyFIX BlueBAG iGUIDE iBEAM

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JAI	Couch, Radiation Therapy, Powered	Radiology	Class 2	892.5770	2021-10-08
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2021-10-08
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2021-10-11
IXQ	Table, Radiographic, Stationary Top	Radiology	Class 2	892.1980	2021-10-11

Official Correspondent

Robert Mitterhauser

US Agent Details

Thomas Valentine Business: Elekta Inc. Email: thomas.valentine@elekta.com Phone: (404) 7972537

Related Public Records

Same Entity

3C-Medical Intelligence 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
K033316	Brainlab AG	TABLE TILT DEVICE	2004-05-14
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

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

Similar Registrations

Registration Number	Establishment Name	Location
3012834372	BizLink Robotic Solutions France	Chartres Eure-et-Loir, FR
1932738	MEDTEC LLC	Orange City, IA, US
2247992	Anholt Technologies Inc.	Avondale, PA, US
3015232217	ELEKTA SOLUTIONS AB	STOCKHOLM, SE
2436865	AKTINA MEDICAL CORP.	Congers, NY, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9710332. Last updated year: 2026. Please use registration number 9710332 when referencing this establishment in official correspondence.