CARDIUS 1, 2 AND 3 XPO AND 2020TC SPECT IMAGING SYSTEMS
FDA 510(k) clearance K070542 · decided 2007-03-23
Clearance details
- K-number
- K070542
- Device name
- CARDIUS 1, 2 AND 3 XPO AND 2020TC SPECT IMAGING SYSTEMS
- Applicant
- Digirad Corp.
- Decision
- Substantially Equivalent
- Date received
- 2007-02-26
- Decision date
- 2007-03-23
- Days to decision
- 25 days
- Clearance type
- Special
- Product code
- KPS
- Device class
- 2
- Regulation number
- 892.1200
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Poway, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.