The following data is part of a premarket notification filed by Toshiba America Medical Systems, Inc. with the FDA for Infinix-i Interventional Angiography System Model Infx-8000v.
| Device ID | K101868 |
| 510k Number | K101868 |
| Device Name: | INFINIX-I INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000V |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | TOSHIBA AMERICA MEDICAL SYSTEMS, INC. 2441 MICHELLE DR Tustin, CA 92780 |
| Contact | Paul Biggins |
| Correspondent | Paul Biggins TOSHIBA AMERICA MEDICAL SYSTEMS, INC. 2441 MICHELLE DR Tustin, CA 92780 |
| Product Code | OWB |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-02 |
| Decision Date | 2010-09-07 |
| Summary: | summary |