# Digirad Corp.

- Location (FDA's records): Poway, CA
- FDA decisions: 16 (1983–2013): 16 510(k) clearances
- Product codes: KPS (10), IYX (3), LQA (1), LLZ (1)
- Predicates its devices cite: 37 (24 its own); citations of its devices by later devices: 31 (24 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Smv America: 4 (https://510kreport.com/company/smv-america)
- Scinticor, Inc.: 2 (https://510kreport.com/company/scinticor)
- Ge Medical Systems F.I. Haifa: 2 (https://510kreport.com/company/ge-medical-systems-fi-haifa)
- Adac Laboratories: 1 (https://510kreport.com/company/adac-laboratories)
- Philips Medical Systems (Cleveland), Inc.: 1 (https://510kreport.com/company/philips-medical-systems-cleveland)
- Sitco, Inc.: 1 (https://510kreport.com/company/sitco)
- Gamma Medica-Ideas Incorporated: 1 (https://510kreport.com/company/gamma-medica-ideas)
- Segami Corporation: 1 (https://510kreport.com/company/segami)

## Firms that cite its devices most
- Acrorad Co., Ltd.: 1 (https://510kreport.com/company/acrorad)
- Health Policy Resorters Group, LLC: 1 (https://510kreport.com/company/health-policy-resorters-group)
- Gvi Technology Partners: 1 (https://510kreport.com/company/gvi-technology-partners)
- Mimvista Corp.: 1 (https://510kreport.com/company/mimvista)
- Gamma Medica: 1 (https://510kreport.com/company/gamma-medica)
- Dilon Technologies, Inc.: 1 (https://510kreport.com/company/dilon-technologies)
- Cardiarc, Ltd.: 1 (https://510kreport.com/company/cardiarc)

## Its most-cited devices
- K982855: Digirad 2020TC Spect Imaging System (1998), cited by 7
- K030085: Cardius-1 and Cardis-2 (2003), cited by 4
- K961104: Notebook Imager (1997), cited by 4
- K051549: Cardius-1, Cardius-2, Cardius-3, 2020TC Spect Imaging System (2005), cited by 4
- K070542: Cardius 1, 2 and 3 Xpo and 2020TC Spect Imaging Systems (2007), cited by 4
- K100838: Ergo Imaging System (2010), cited by 2

## Recent decisions
- K123408: Ergo Imaging System (Jan 15, 2013)
- K100838: Ergo Imaging System (Apr 23, 2010)
- K083649: Cardius 3 X-Act (Mar 9, 2009)
- K082904: Stasys Motion Correction Software (Dec 17, 2008)
- K082368: Cardius-1, -2, -3, and Cardius 1,2,3 Xpo Spect Imaging Systems, 2020TC Spect Imaging System (Sep 12, 2008)
- K070542: Cardius 1, 2 and 3 Xpo and 2020TC Spect Imaging Systems (Mar 23, 2007)
- K052430: Cardius-1, Cardius-2, Cardius-3, 2020TC Spect Imaging System (Oct 4, 2005)
- K051549: Cardius-1, Cardius-2, Cardius-3, 2020TC Spect Imaging System (Jul 13, 2005)

Source page: https://510kreport.com/company/digirad