The following data is part of a premarket notification filed by Toshiba Medical Systems Corporation with the FDA for Infx-8000v, V5.30.
| Device ID | K133535 |
| 510k Number | K133535 |
| Device Name: | INFX-8000V, V5.30 |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | TOSHIBA MEDICAL SYSTEMS CORPORATION 2441 MICHELLE DRIVE Tustin, CA 92780 |
| Contact | Charlemagne Chua |
| Correspondent | Charlemagne Chua TOSHIBA MEDICAL SYSTEMS CORPORATION 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 | 2013-11-18 |
| Decision Date | 2014-07-23 |
| Summary: | summary |