The following data is part of a premarket notification filed by Toshiba Medical Systems Corporation with the FDA for Infx-8000c, V6.20.
| Device ID | K152697 |
| 510k Number | K152697 |
| Device Name: | INFX-8000C, V6.20 |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | TOSHIBA MEDICAL SYSTEMS CORPORATION 1385 SHIMOISHIGAMI Otawara-shi, JP 324-8550 |
| Contact | Janine Reyes |
| Correspondent | Janine Reyes TOSHIBA AMERICA MEDICAL SYSTEMS, INC. 2441 MICHELLE DR. 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 | 2015-09-21 |
| Decision Date | 2016-01-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04987670100192 | K152697 | 000 |