FDA.reportPublic FDA data

Spectrum Dynamics Medical Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30080073103008007310Spectrum Dynamics Medical Inc.1Y2026-01-01301 N. Cattlemen Rd. Suite 109 Sarasota FL US 34232

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1597051147052839K230600VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464)KPS2023-04-28
1597051111926954K212230TruSPECT Radiological Image Processing StationLLZ2021-08-16
1597051348968376K190457VERITON CT whole body SPECT/CT systemKPS2019-07-12
1597051004438678K182484VERITON CT whole body SPECT/CT systemKPS2018-11-09
1597051831639130K180514VERITON NMKPS2018-04-25
1597051449534596K161740D-SPECT Scanner, D-SPECT L ScannerKPS2016-11-04
1597051909726882K160120D-SPECT Processing and Reviewing WorkstationKPS2016-03-21
1597051176060975K110507CARDIAC SCANNER AND PROCESSING SYSTEMKPS2011-07-13

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KPS102023-04-28
LLZ12021-08-16

PMN#

VERITON NM

2018-04-25

Spectrum Dynamics Medical Ltd.

GUDID#