IBA Dosimetry America

FDA Device Registration & Listing · Herndon, VA, US · Registration 1062572

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1062572
FEI Number
3001238439
Entity Name
IBA Dosimetry America
City/State/Country
Herndon, VA, US
Establishment Address
470 Springpark Place, Suite #700, Herndon, VA 20170, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198
Owner / Operator
IBA Dosimetry GmbH (Owner Number: 9011908)
Owner / Operator Contact Address
BAHNHOFSTRASSE 5, --, SCHWARZENBRUCK, DE-BY D-90592, DE
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K191821
PMA Number
N/A

All Registered Proprietary Names

Blue Phantom PT

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LHN System, Radiation Therapy, Charged-Particle, Medical Radiology Class 2 892.5050 2020-01-27

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

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
9614952 IBA Dosimetry GmbH SCHWARZENBRUCK Bavaria, DE

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0014-2009 Intraop Medical Corporation 2
Mobetron Model 1000, mobile electron linear accelerator, a device system which delivers radiation to an intraoperative site.

Similar Registrations

Registration Number Establishment Name Location
3016872563 EHMET HEALTH Plymouth, MI, US
3015232217 ELEKTA SOLUTIONS AB STOCKHOLM, SE
8043933 BRAINLAB SE Munich Bavaria, DE
3010658895 Varian Medical Systems Particle Therapy GmbH & Co. KG Troisdorf North Rhine-Westphalia, DE
8031557 ANZAI MEDICAL CO, LTD. SHINAGAWA-KU Tokyo, JP
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1062572. Last updated year: 2026. Please use registration number 1062572 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.