FDA.reportPublic FDA data

IBA

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
10625723001238439IBA Dosimetry America1Y2026-01-01470 Springpark Place, Suite #700 Herndon VA US 20170
96149523006653576IBA Dosimetry GmbH1N2026-01-01Bahnhofstrasse 5 SCHWARZENBRUCK Bavaria DE D-90592
30133788213013378821IBA PROTON THERAPY, INC.1Y2026-01-01470 Spring Park Place Suite 700 Herndon VA US 20170

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
153331777165817K990734DPD-12PCCIYE1999-05-28
153331359721310K961400RFA-300, LDA UTILITYIYE1997-01-03
153331112563449K945321WELLHOFER WP700 V. 3.2IYE1995-07-12
153331643637044K942092DPD-3IYE1994-07-29
153331131433552K934303RFA A-300IYE1994-08-09
153331855535695K201798myQA iONLHN2020-07-17
153341833186856K191821Blue Phantom PTLHN2020-01-23
153331833186856K191821Blue Phantom PTLHN2020-01-23
153331260946139K092018OMNIPRO INCLINEIYE2009-09-18
153331855484601K072374COMPASSIYE2007-12-07
153331615042609K032594ONE DIMENSIONAL WATER PHANTOM, WP 1DIYE2003-09-05
153331031117589K031634OMNIPRO I'MRTIYE2003-08-29
153331000135099K011763OMNIDOSIYE2001-09-05
153331757567463K000209DOSE 1IYE2000-08-18
153331255100184
153331438663382
153331869286002
153332005376280

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
IYE112009-09-18
LHN32020-07-17

PMN#