The following data is part of a premarket notification filed by Canon Medical Systems Corporation with the FDA for Cartesion Prime (pcd-1000a/3) V10.8.
| Device ID | K203314 |
| 510k Number | K203314 |
| Device Name: | Cartesion Prime (PCD-1000A/3) V10.8 |
| Classification | System, Tomography, Computed, Emission |
| Applicant | Canon Medical Systems Corporation 1385 Shimoishigami Otawara-shi, JP 324-8550 |
| Contact | Paul Biggins |
| Correspondent | Orlando Tadeo, Jr. Canon Medical Systems USA, 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 | 2020-11-10 |
| Decision Date | 2021-04-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04987670103810 | K203314 | 000 |