The following data is part of a premarket notification filed by Toshiba America Medical Systems, Inc. with the FDA for Drad-3000e, Radrex-i.
| Device ID | K073165 |
| 510k Number | K073165 |
| Device Name: | DRAD-3000E, RADREX-I |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | TOSHIBA AMERICA MEDICAL SYSTEMS, INC. 2441 MICHELLE DR. P.O. BOX 2068 Tustin, CA 92781 -2068 |
| Contact | Paul Biggins |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2007-11-09 |
| Decision Date | 2007-11-16 |
| Summary: | summary |