The following data is part of a premarket notification filed by Hamamatsu Photonics, K.k. with the FDA for Hamamatsu Pet Scanner, Model Shr-22000.
| Device ID | K982171 |
| 510k Number | K982171 |
| Device Name: | HAMAMATSU PET SCANNER, MODEL SHR-22000 |
| Classification | System, Tomography, Computed, Emission |
| Applicant | HAMAMATSU PHOTONICS, K.K. 12300 TWINBROOK PKWY. SUITE 625 Rockville, MD 20852 |
| Contact | T. Whit Athey |
| Correspondent | T. Whit Athey HAMAMATSU PHOTONICS, K.K. 12300 TWINBROOK PKWY. SUITE 625 Rockville, MD 20852 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-19 |
| Decision Date | 1998-09-17 |
| Summary: | summary |