The following data is part of a premarket notification filed by Toshiba Medical Systems Corporation with the FDA for Infinix-i, Infx-8000v, V7.0.
| Device ID | K172863 |
| 510k Number | K172863 |
| Device Name: | Infinix-i, INFX-8000V, V7.0 |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | Toshiba Medical Systems Corporation 1385 Shimoishigami Otawara-shi, JP 324-8550 |
| Contact | Paul Biggins |
| Correspondent | Janine F. Reyes Toshiba America Medical Systems, Inc. 2441 Michelle Drive Tustin, CA 92780 |
| Product Code | OWB |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-20 |
| Decision Date | 2017-12-14 |
| Summary: | summary |