Digirad Corp.: FDA filings under this applicant name
FDA lists 16 510(k) clearances under the applicant name “Digirad Corp.” (first 1983, latest 2013), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 68 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 71 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KPS | System, Tomography, Computed, Emission | 10 | 10 |
| IYX | Camera, Scintillation (Gamma) | 3 | 3 |
| LLZ | System, Image Processing, Radiological | 1 | 1 |
| LQA | Media, Reusable Image | 1 | 1 |
Plus 1 more product codes.
Review panels
- Radiology (15)
Most recent Digirad Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K123408 | ERGO IMAGING SYSTEM | IYX | 2013-01-15 | 71 |
| K100838 | ERGO IMAGING SYSTEM | IYX | 2010-04-23 | 30 |
| K083649 | CARDIUS 3 X-ACT | KPS | 2009-03-09 | 90 |
| K082904 | STASYS MOTION CORRECTION SOFTWARE | KPS | 2008-12-17 | 78 |
| K082368 | CARDIUS-1, -2, -3, AND CARDIUS 1,2,3 XPO SPECT IMAGING SYSTEMS, 2020TC SPECT IMAGING SYSTEM | KPS | 2008-09-12 | 25 |
| K070542 | CARDIUS 1, 2 AND 3 XPO AND 2020TC SPECT IMAGING SYSTEMS | KPS | 2007-03-23 | 25 |
| K052430 | CARDIUS-1, CARDIUS-2, CARDIUS-3, 2020TC SPECT IMAGING SYSTEM | KPS | 2005-10-04 | 28 |
| K051549 | CARDIUS-1, CARDIUS-2, CARDIUS-3, 2020TC SPECT IMAGING SYSTEM | KPS | 2005-07-13 | 30 |
| K030085 | CARDIUS-1 AND CARDIS-2 | KPS | 2003-02-05 | 27 |
| K023110 | CEDARS-SINAI MOTION CORRECTION (MOCO) SOFTWARE, MODEL 111005 | KPS | 2002-11-22 | 64 |
6 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Digirad Corp..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Digirad Corp.?
FDA lists 16 510(k) clearances under the applicant name “Digirad Corp.” (first 1983, latest 2013), across 5 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Digirad Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Digirad Corp. is 68 days.
Which FDA product codes appear under Digirad Corp.?
The most frequent FDA product codes under this applicant name are KPS (System, Tomography, Computed, Emission, 10); IYX (Camera, Scintillation (Gamma), 3); LLZ (System, Image Processing, Radiological, 1).
Next steps
- See all 16 Digirad Corp. clearances with predicates and recalls
- Run predicate analysis for product code KPS, Digirad Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.