The following data is part of a premarket notification filed by Toshiba Medical Systems Corporation with the FDA for Vitrea Software Toshiba Package, Vstp-001a.
| Device ID | K151091 |
| 510k Number | K151091 |
| Device Name: | Vitrea Software Toshiba Package, VSTP-001A |
| Classification | System, Image Processing, Radiological |
| 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 | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-04-23 |
| Decision Date | 2015-07-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04987670102493 | K151091 | 000 |