Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9614952

FEI Number

3006653576

Entity Name

IBA Dosimetry GmbH

City/State/Country

SCHWARZENBRUCK Bavaria, DE

Establishment Address

Bahnhofstrasse 5, SCHWARZENBRUCK Bavaria D-90592, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

IBA Dosimetry GmbH (Owner Number: 9011908)

Owner / Operator Contact Address

BAHNHOFSTRASSE 5, --, SCHWARZENBRUCK, DE-BY D-90592, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K945321

PMA Number

N/A

All Registered Proprietary Names

ONE DIMENSIONAL WATER PHANTOM, WP 1D DPD-3 myQA iON Dose 1 with different Ionization chambers (e.g. FC65-P, PPC40) OmniPro Incline incl MLIC Zebra, Giraffe DPD-12PC incl 2D Detector Arrays: Transmission Detector Dolphin, I'mRT MatriXX and MatriXX Evolution Compass myQA Cockpit RFA-300 UTILITY LDA-99 SC incl electometer emXX Sphinx Compact, myQA Phoenix SMfit KermaX myQA Daily, DOSE-X QA Crosschecker, myQA StarTrack3 MagicMax / MagicMax Universal with different detectors, Dosimax with different detectors, OmniPro Advance with StarTrack myQA Machines with StarTrack, myQA FastTrack, Sphinx, myQA FastTrack PT RFA A-300 myQA Accept including accessories: Lift Table, Water reservoir, myQA Quicklevel Blue Phantom 2, myQA Blue Phantom 3 Blue Phantom Helix, Blue Phantom Compact, Blue Phantom SmartScan Stealth Chamber, CC04, CC08, CC-13S, CC13, CC25, FC23-C, with different detectors: Semiconductor detectors and chambers: NACP, CC13, FC65-P, FC65-G, PPC05, PPC40 Razor Chamber, Razor Nanochamber, Razor Detector,

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2008-01-03
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2008-01-03
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2020-07-27
LHN	System, Radiation Therapy, Charged-Particle, Medical	Radiology	Class 2	892.5050	2020-07-27
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2008-01-03
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2009-11-26
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2008-01-03
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2008-01-03
OUG	Medical Device Data System	General Hospital	Class 1	880.6310	2015-06-09
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2008-01-03
LHO	Instrument, Quality-Assurance, Radiologic	Radiology	Class 1	892.1940	1999-09-29
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2008-01-03
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2008-01-03
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2008-01-03

Official Correspondent

Andreas Suchi

US Agent Details

Nick Narloch Business: IBA Dosimetry America, Inc. Email: nick.narloch@iba-group.com Phone: (901) 8055767

Related Public Records

Same Entity

IBA Dosimetry GmbH

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
1062572	IBA Dosimetry America	Herndon, VA, US

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

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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3007791541	Varian Medical Systems China Co., Ltd.	Beijing, CN
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9614952. Last updated year: 2026. Please use registration number 9614952 when referencing this establishment in official correspondence.