The following data is part of a premarket notification filed by Toshiba America Medical Systems, Inc. with the FDA for Infinix-cci.
| Device ID | K113052 |
| 510k Number | K113052 |
| Device Name: | INFINIX-CCI |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| 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 | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-10-13 |
| Decision Date | 2011-11-22 |
| Summary: | summary |