IBA Dosimetry GmbH

Herndon, VA, US

IBA Dosimetry GmbH appears in FDA device records in Herndon, VA. FDA records list 3 510(k) clearances between 2009-09-18 and 2020-07-17, no PMA records and 2 registered establishments. As of 2026-09-10, FDA records show 6 recalls for this company, and at least one establishment registration is current.

510(k) clearances: 3
PMA records: 0
Recall records: 6
Registered establishments: 2

FDA records under these names

1 name

FDA records resolved to IBA Dosimetry GmbH carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

IBA Dosimetry Americaregistration

510(k) clearance history

FDA records hold 3 510(k) clearances for IBA Dosimetry GmbH between 2009 and 2020. The busiest year on record is 2020, with 2. The most recent is 2020, with 2.

Clearances by year, as a table

510(k) clearance decisions for IBA Dosimetry GmbH, by decision year
Year	Clearances
2009	1
2020	2

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K201798	myQA iON	LHN	Substantially Equivalent	2020-07-17
K191821	Blue Phantom PT	LHN	Substantially Equivalent	2020-01-23
K092018	OMNIPRO INCLINE	IYE	Substantially Equivalent	2009-09-18

Registered establishments

FDA registered establishments for IBA Dosimetry GmbH, with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
1062572	3001238439	IBA Dosimetry America	470 Springpark Place, Suite #700, Herndon, VA 20170 US	2026	LHN
9614952	3006653576	IBA Dosimetry GmbH	Bahnhofstrasse 5, SCHWARZENBRUCK Bavaria D-90592 DE	2026	IXG IYE LHN LHO MWW OUG

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-1703-2025	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.	Class II	2025-04-01	Open, Classified
Z-2220-2017	Large Stealth Chamber, Catalog Numbers: DS50-001-XL-T, DS50-002-XL-T, DS50-003-XL-T, DS50-102-XL-T, DS50-103-XL-T	When the Stealth Chamber is used as a reference detector in relative dosimetry, deviation in the measured PDDs at shallow depths and geometric shadowing of measured profiles may appear.	Class II	2017-04-26	Terminated
Z-0683-2016	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.	Class II	2015-12-10	Terminated
Z-1212-2015	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.	Class II	2015-02-02	Terminated
Z-0168-2015	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.	Class II	2014-09-25	Terminated
Z-0456-2014	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.	Class II	2013-08-20	Terminated

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.

What MDM checks, and what it does not

MDM coverage

MDM coverage of this company lists here, newest first. Submit news.

Is this your company?

This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.

Claiming lets IBA Dosimetry GmbH edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.

Claim this page

Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain