K982171 is an FDA 510(k) clearance for the HAMAMATSU PET SCANNER, MODEL SHR-22000. This device is classified as a System, Tomography, Computed, Emission (Class II - Special Controls, product code KPS).
Submitted by Hamamatsu Photonics K.K. (Rockville, US). The FDA issued a Cleared decision on September 17, 1998, 90 days after receiving the submission on June 19, 1998.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1200.
| 510(k) Number | K982171 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 19, 1998 |
| Decision Date | September 17, 1998 |
| Days to Decision | 90 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 |