The following data is part of a premarket notification filed by Toshiba Medical Systems Corporation with the FDA for Infinix, Infx-8000v, V6.35.
| Device ID | K162614 |
| 510k Number | K162614 |
| Device Name: | Infinix, INFX-8000V, V6.35 |
| 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 |
| Subsequent Product Code | IZI |
| Subsequent Product Code | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-19 |
| Decision Date | 2016-10-17 |
| Summary: | summary |