The following data is part of a premarket notification filed by Toshiba Medical Systems Corporation with the FDA for Celesteion, Pca-9000a/2.
| Device ID | K140651 |
| 510k Number | K140651 |
| Device Name: | CELESTEION, PCA-9000A/2 |
| Classification | System, Tomography, Computed, Emission |
| Applicant | TOSHIBA MEDICAL SYSTEMS CORPORATION 2441 MICHELLE DRIVE Tustin, CA 92780 |
| Contact | Paul Biggins |
| Correspondent | Paul Biggins TOSHIBA MEDICAL SYSTEMS CORPORATION 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 | 2014-03-13 |
| Decision Date | 2014-06-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04987670100543 | K140651 | 000 |