The following data is part of a premarket notification filed by Toshiba Medical Systems Corporation with the FDA for Aquilion Prime, V5.00.
| Device ID | K130645 |
| 510k Number | K130645 |
| Device Name: | AQUILION PRIME, V5.00 |
| Classification | System, X-ray, Tomography, Computed |
| 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 | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-11 |
| Decision Date | 2013-06-06 |
| Summary: | summary |