FDA.reportPublic FDA data

Digirad Diagnostic Imaging, LLC

Matched from indexed company URL: DIGIRAD CORP.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
20310503001236767Digirad Diagnostic Imaging, LLC1N2026-01-0113100 Gregg St Ste A POWAY CA US 92064

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00850816007102Cardius X-Act - Domestic8587261600callcenter@digirad.com
00850816007119Cardius X-Act - International8587261600callcenter@digirad.com
00850816007126LEAP Collimator - LEAP8587261600callcenter@digirad.com
00850816007133MEAP Collimator - MEAP8587261600callcenter@digirad.com
00850816007140PINHOLE Collimator - PINHOLE8587261600callcenter@digirad.com
00850816007157Diverging Collimator - Diverging8587261600callcenter@digirad.com
00850816007164Mamo Collimator - Mamo8587261600callcenter@digirad.com
00850816007195Breast Imaging Accessory - BIA8587261600callcenter@digirad.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
537851505971787K961104NOTEBOOK IMAGERIYX1997-05-28
537851562810523K123408ERGO IMAGING SYSTEMIYX2013-01-15
537852056168753K052430CARDIUS-1, CARDIUS-2, CARDIUS-3, 2020TC SPECT IMAGING SYSTEMKPS2005-10-04

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
IYX22013-01-15
KPS12005-10-04

PMN#

GUDID#