510(k) Report

FDA applicant

Digirad Corp.

Poway, CA16 decisions1983–20130 recalls

FDA records 16 decisions for Digirad Corp. (Poway, CA) from 1983 to 2013: 16 510(k) clearances. Most are in product codes KPS (System, Tomography, Computed, Emission) and IYX (Camera, Scintillation (Gamma)). Its devices cite 37 predicates, 24 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided Digirad Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2007: 12008: 22009: 12010: 12013: 1
2007high 2 (2008) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Digirad Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Digirad Corp.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • KPSSystem, Tomography, Computed, Emission10decisions
  • IYXCamera, Scintillation (Gamma)3decisions
  • LQAMedia, Reusable Image1decision
  • LLZSystem, Image Processing, Radiological1decision

Whose devices does it build on?

Its devices cite 37 predicates; 24 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 31 times; 24 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K982855Digirad 2020TC Spect Imaging SystemDigirad Corp. · 19987cite it
  • K030085Cardius-1 and Cardis-2Digirad Corp. · 20034cite it
  • K961104Notebook ImagerDigirad Corp. · 19974cite it
  • K051549Cardius-1, Cardius-2, Cardius-3, 2020TC Spect Imaging SystemDigirad Corp. · 20054cite it
  • K070542Cardius 1, 2 and 3 Xpo and 2020TC Spect Imaging SystemsDigirad Corp. · 20074cite it
  • K100838Ergo Imaging SystemDigirad Corp. · 20102cite it

What has FDA decided for it lately?

  • K123408Ergo Imaging SystemDigirad Corp. · 2013
  • K100838Ergo Imaging SystemDigirad Corp. · 2010
  • K083649Cardius 3 X-ActDigirad Corp. · 2009
  • K082904Stasys Motion Correction SoftwareDigirad Corp. · 2008
  • K082368Cardius-1, -2, -3, and Cardius 1,2,3 Xpo Spect Imaging Systems, 2020TC Spect Imaging SystemDigirad Corp. · 2008
  • K070542Cardius 1, 2 and 3 Xpo and 2020TC Spect Imaging SystemsDigirad Corp. · 2007
  • K052430Cardius-1, Cardius-2, Cardius-3, 2020TC Spect Imaging SystemDigirad Corp. · 2005
  • K051549Cardius-1, Cardius-2, Cardius-3, 2020TC Spect Imaging SystemDigirad Corp. · 2005

All 16 as Digirad Corp. →