Data / Medical devices / United States / IBA Dosimetry America

IBA Dosimetry America: FDA-registered device maker in Herndon, VA, United States, 1 510(k) clearance

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

IBA Dosimetry America is registered with the FDA (registration 1062572) in Herndon, VA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated January 23, 2020. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this one Watch IBA Dosimetry America

FDA registration number: 1062572
FEI number: 3001238439
Address: 470 Springpark Place, Suite #700, Herndon, VA, United States, 20170
Owner or operator: IBA Dosimetry GmbH (9011908)
Roles: Complaint file establishment
First device listed: January 27, 2020
Registered through: 2026
Brand names listed: Blue Phantom PT

Devices it lists

Device	Product code	Class	Role	Source
System, Radiation Therapy, Charged-Particle, Medical	LHN	2	Complaint file establishment	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
January 23, 2020	K191821	Blue Phantom PT	LHN	Substantially Equivalent	Iba Dosimetry GmbH	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 26, 2017	77301	Class II	Terminated	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.	accessdata.fda.gov

Compare with other makers

All makers of System, Radiation Therapy, Charged-Particle, Medical

Updated January 23, 2020. 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.