The following data is part of a premarket notification filed by Toshiba America Medical Systems, Inc. with the FDA for Infx-8000h, Infinix-i.
| Device ID | K082830 |
| 510k Number | K082830 |
| Device Name: | INFX-8000H, INFINIX-I |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | TOSHIBA AMERICA MEDICAL SYSTEMS, INC. 2441 MICHELLE DR. Tustin, CA 92780 -2068 |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | JAA |
| Subsequent Product Code | IZI |
| Subsequent Product Code | MQB |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-09-26 |
| Decision Date | 2008-10-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04987670100215 | K082830 | 000 |