Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Digirad Corp. — Predicate Candidate Screening

16 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

71 daysmedian FDA review time
169 days90th percentile
16clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K123408ERGO IMAGING SYSTEMDigirad Corp.2013-01-15710
K100838ERGO IMAGING SYSTEMDigirad Corp.2010-04-23300
K083649CARDIUS 3 X-ACTDigirad Corp.2009-03-09900
K082904STASYS MOTION CORRECTION SOFTWAREDigirad Corp.2008-12-17780
K082368CARDIUS-1, -2, -3, AND CARDIUS 1,2,3 XPO SPECT IMAGING SYSTEDigirad Corp.2008-09-12250
K070542CARDIUS 1, 2 AND 3 XPO AND 2020TC SPECT IMAGING SYSTEMSDigirad Corp.2007-03-23250
K052430CARDIUS-1, CARDIUS-2, CARDIUS-3, 2020TC SPECT IMAGING SYSTEMDigirad Corp.2005-10-04280
K051549CARDIUS-1, CARDIUS-2, CARDIUS-3, 2020TC SPECT IMAGING SYSTEMDigirad Corp.2005-07-13300
K030085CARDIUS-1 AND CARDIS-2Digirad Corp.2003-02-05270
K023110CEDARS-SINAI MOTION CORRECTION (MOCO) SOFTWARE, MODEL 111005Digirad Corp.2002-11-22640
K011572QUANTITATIVE GATED SPECT (QGS), QUANTITATIVE PERFUSION SPECTDigirad Corp.2001-06-15250
K982855DIGIRAD 2020TC SPECT IMAGING SYSTEMDigirad Corp.1998-11-04900
K961104NOTEBOOK IMAGERDigirad Corp.1997-05-284340
K854407DIGIRAD REUSABLE IMAGE MEDIADigirad Corp.1986-03-101290
K852284DIGIRAD SYSTEM 1 AND THE REUSUABLE IMAGE MEDIADigirad Corp.1985-11-141690
K828562DIGIRAD CFR 2000 RADIOGRAPHIC FILM CASSETTEDigirad Corp.1983-04-281630

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda