FDA.reportPublic FDA data

ISORAY MEDICAL, INC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30055200393005520039ISORAY MEDICAL, INC1N2020-04-25350 Hills St Ste 106 RICHLAND WA US 99354

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
614971281600029K180515GammaTileKXK2018-07-06
614971490232814K132996CESITRX, (LIQUID CESIUM-131 SOLUTION) FOR USE WITH GLIASITE RTSKXK2013-12-17
614971168428179K111931GLIASITE RTSKXK2011-08-05
614972049649441K092458PROXCELAN CS-131PRELOADED STRANDS, MODEL PL-1, PROXCELAN CS-131 PRELOADED STRANDS IN 18 GUAGE NEEDLES, MODEL PL-2KXK2009-08-28
614971980917249K092136PROXCELAN CS-131 PRELOADED BRAIDED STRANDS, MODEL: PL-5KXK2009-08-07
614971688116091K062384CESIUM-131 STRAND, STRAND PRELOAD, PRELOAD, S-CARTRIDGEKXK2006-11-09
614971002895570K030162LAWRENCE CSERION, MODEL CS-1KXK2003-03-28
614971450050094

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KXK72018-07-06