K231731 is an FDA 510(k) clearance for the Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 4. This device is classified as a System, Tomography, Computed, Emission (Class II - Special Controls, product code KPS).
Submitted by Mcgovern Medical School (Houston, US). The FDA issued a Cleared decision on August 21, 2023, 69 days after receiving the submission on June 13, 2023.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1200.
| 510(k) Number | K231731 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 13, 2023 |
| Decision Date | August 21, 2023 |
| Days to Decision | 69 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | KPS - System, Tomography, Computed, Emission |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1200 |