Data / Medical devices / Germany / IBA Dosimetry GmbH

IBA Dosimetry GmbH: FDA-registered device maker in SCHWARZENBRUCK Bavaria, Germany, 13 510(k) clearances

Name: IBA Dosimetry GmbH FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

IBA Dosimetry GmbH is registered with the FDA (registration 9614952) in SCHWARZENBRUCK Bavaria, Germany. It lists 6 device types. The FDA files 13 510(k) clearances under its listings, the newest dated July 17, 2020. 5 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 9614952
FEI number: 3006653576
Address: Bahnhofstrasse 5, SCHWARZENBRUCK Bavaria, Germany, D-90592
Owner or operator: IBA Dosimetry GmbH (9011908)
Roles: Contract manufacturer, Manufacturer
First device listed: November 15, 1994
Registered through: 2026
Brand names listed: Blue Phantom 2, myQA Blue Phantom 3, Blue Phantom Helix, Blue Phantom Compact, Blue Phantom SmartScan, Blue Phantom PT, Compass, DPD-12PC, DPD-3, DigiPhant PT, Dose 1 and more

Devices it lists

Device	Product code	Class	Role	Source
Accelerator, Linear, Medical	IYE	2	Manufacturer	accessdata.fda.gov
Accessory - Film Dosimetry System	MWW	2	Manufacturer	accessdata.fda.gov
Instrument, Quality-Assurance, Radiologic	LHO	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Medical Device Data System	OUG	1	Manufacturer	accessdata.fda.gov
Phantom, Anthropomorphic, Radiographic	IXG	1	Manufacturer	accessdata.fda.gov
System, Radiation Therapy, Charged-Particle, Medical	LHN	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
July 17, 2020	K201798	myQA iON	LHN	Substantially Equivalent	Iba Dosimetry GmbH	accessdata.fda.gov
January 23, 2020	K191821	Blue Phantom PT	LHN	Substantially Equivalent	Iba Dosimetry GmbH	accessdata.fda.gov
September 18, 2009	K092018	OMNIPRO INCLINE	IYE	Substantially Equivalent	Iba Dosimetry GmbH	accessdata.fda.gov
December 7, 2007	K072374	COMPASS	IYE	Substantially Equivalent	Scanditronix Wellhofer GmbH	accessdata.fda.gov
September 5, 2003	K032594	ONE DIMENSIONAL WATER PHANTOM, WP 1D	IYE	Substantially Equivalent	Wellhofer Dosimetrie	accessdata.fda.gov
August 29, 2003	K031634	OMNIPRO I'MRT	IYE	Substantially Equivalent	Wellhofer Dosimetrie	accessdata.fda.gov
September 5, 2001	K011763	OMNIDOS	IYE	Substantially Equivalent	Scanditronix Medical AB	accessdata.fda.gov
August 18, 2000	K000209	DOSE 1	IYE	Substantially Equivalent	Scanditronix Wellhofer North America	accessdata.fda.gov
May 28, 1999	K990734	DPD-12PCC	IYE	Substantially Equivalent	Scanditronix Medical AB	accessdata.fda.gov
January 3, 1997	K961400	RFA-300, LDA UTILITY	IYE	Substantially Equivalent	Scanditronix Medical AB	accessdata.fda.gov
July 12, 1995	K945321	WELLHOFER WP700 V. 3.2	IYE	Substantially Equivalent	Medical Physics Instrumentation, Inc.	accessdata.fda.gov
August 9, 1994	K934303	RFA A-300	IYE	Substantially Equivalent	Scanditronix, Inc.	accessdata.fda.gov
July 29, 1994	K942092	DPD-3	IYE	Substantially Equivalent	Scanditronix, Inc.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
April 1, 2025	96647	Class II	Ongoing	myQA iON; Article Number: MQ10-000	Wrong analysis results can occur if the user creates two structures with the same name, except for one differing by a special character.	accessdata.fda.gov
December 10, 2015	73036	Class II	Terminated	IBA Dosimetry GmbH Lift Table Type 4320, Catalog HA03-010#2 and HA03-000#2	When the electric lift table is connected to the mains power, in a very rare occasion, the table may start to move up in an uncontrolled manner.	accessdata.fda.gov
February 2, 2015	70545	Class II	Terminated	COMPASS SW Version 3.1, Catalog Number CS10-100, medical linear accelerator, radiological	Error in the software. During internal tests of the current development version of the Compass SW it was found that dose reconstruction for DMLC plans when the jaws move or mlc leaves reverse during beam on will not be scaled correctly for all control points.	accessdata.fda.gov
September 25, 2014	69583	Class II	Terminated	COMPASS, Model No. SW Version 3.1, catalogue number CS10-100 (medical Linear accelerator) radiological	Error in the software. A deviation between reconstructed and planned dose distribution may not be detected prior to treatment and this can result in an over or under-estimation of the pretreatment delivered dose.	accessdata.fda.gov
August 20, 2013	66808	Class II	Terminated	iba COMPASS SW Version 3.0, Catalog Number CS10-100 (medical linear accelerator) radiological	The development partner of IBA informed that there is problem in a SW component used in COMPASS when converting Region of Interest (ROI) geometries to dose grid representation. Under certain conditions this problem generates too large ROI voxel volumes causing erroneous dose statistics and DVHs.	accessdata.fda.gov

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Updated April 30, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.