The following data is part of a premarket notification filed by Toshiba Medical Systems Corporation with the FDA for Aquilion One Vision With First 2.0 (ccrs-001b) V7.4.
| Device ID | K161009 |
| 510k Number | K161009 |
| Device Name: | Aquilion ONE Vision With FIRST 2.0 (CCRS-001B) V7.4 |
| Classification | System, X-ray, Tomography, Computed |
| 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 | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-11 |
| Decision Date | 2016-07-22 |
| Summary: | summary |