The following data is part of a premarket notification filed by Toshiba Medical Systems Corporation with the FDA for Aquilion Prime, V6.00.
| Device ID | K141741 |
| 510k Number | K141741 |
| Device Name: | AQUILION PRIME, V6.00 |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | TOSHIBA MEDICAL SYSTEMS CORPORATION 2441 MICHELLE DRIVE Tustin, CA 92780 |
| Contact | Orlando Tadeo |
| Correspondent | Orlando Tadeo 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 | 2014-06-27 |
| Decision Date | 2014-11-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04987670100659 | K141741 | 000 |