Submission Details
| 510(k) Number | K070542 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 26, 2007 |
| Decision Date | March 23, 2007 |
| Days to Decision | 25 days |
| Submission Type | Special |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
Cleared
Special
CARDIUS 1, 2 AND 3 XPO AND 2020TC SPECT IMAGING SYSTEMS
Mar 2007
Decision
25d
Days
Class 2
Risk
About This 510(k) Submission
K070542 is an FDA 510(k) clearance for the CARDIUS 1, 2 AND 3 XPO AND 2020TC SPECT IMAGING SYSTEMS, a System, Tomography, Computed, Emission (Class II — Special Controls, product code KPS), submitted by Digirad Corp. (Poway, US). The FDA issued a Cleared decision on March 23, 2007, 25 days after receiving the submission on February 26, 2007. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1200.
Device Classification
| Product Code | KPS — System, Tomography, Computed, Emission |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 892.1200 |
Manufacturer
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