CARDIUS-1, CARDIUS-2, CARDIUS-3, 2020TC SPECT IMAGING SYSTEM— 510(k) K051549
Substantially EquivalentDigirad Corp.
FDA 510(k) clearance K051549 for CARDIUS-1, CARDIUS-2, CARDIUS-3, 2020TC SPECT IMAGING SYSTEM, Substantially Equivalent on 2005-07-13. Applicant: Digirad Corp.. Device class: 2.
Clearance details
- Applicant
- Digirad Corp.
- Product code
- Code KPS
- Device class
- Class 2
- Regulation
- 21 CFR 892.1200
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Poway, CA, US
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