The following data is part of a premarket notification filed by Toshiba America Medical Systems, Inc. with the FDA for Radrex-i, Sw V4.00 Model Drad-3000e.
| Device ID | K122842 |
| 510k Number | K122842 |
| Device Name: | RADREX-I, SW V4.00 MODEL DRAD-3000E |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | TOSHIBA AMERICA MEDICAL SYSTEMS, INC. 2441 MICHELLE DR. Tustin, CA 92780 |
| Contact | Charlemagne Chua |
| Correspondent | Charlemagne Chua 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 | 2012-09-17 |
| Decision Date | 2012-10-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04987670102196 | K122842 | 000 |