The following data is part of a premarket notification filed by Toshiba Medical Systems Corporation, Japan with the FDA for Infinix Cf-i/sp And Infinix Vf-i/sp Model Infx-8000v.
| Device ID | K112054 |
| 510k Number | K112054 |
| Device Name: | INFINIX CF-I/SP AND INFINIX VF-I/SP MODEL INFX-8000V |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | TOSHIBA MEDICAL SYSTEMS CORPORATION, JAPAN 2441 MICHELLE DR Tustin, CA 92780 |
| Contact | Paul Biggins |
| Correspondent | Paul Biggins TOSHIBA MEDICAL SYSTEMS CORPORATION, JAPAN 2441 MICHELLE DR Tustin, CA 92780 |
| Product Code | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-07-19 |
| Decision Date | 2011-08-05 |
| Summary: | summary |