The following data is part of a premarket notification filed by Toshiba Medical Systems Corporation with the FDA for Celesteion, Pca-9000a/3.
| Device ID | K170490 |
| 510k Number | K170490 |
| Device Name: | Celesteion, PCA-9000A/3 |
| Classification | System, Tomography, Computed, Emission |
| Applicant | Toshiba Medical Systems Corporation 1385 Shimoishigami Otawara-shi, JP 324-8550 |
| Contact | Paul Biggins |
| Correspondent | Orlando Tadeo Toshiba America Medical Systems, Inc. 2441 Michelle Drive Tustin, CA 92780 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-02-17 |
| Decision Date | 2017-06-01 |
| Summary: | summary |