The following data is part of a premarket notification filed by Toshiba America Medical Systems, Inc. with the FDA for Dua-900a Image-intensified Fluoroscopic X-ray Syst.
| Device ID | K922364 |
| 510k Number | K922364 |
| Device Name: | DUA-900A IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYST |
| Classification | Table, Radiographic, Tilting |
| Applicant | TOSHIBA AMERICA MEDICAL SYSTEMS, INC. 2441 MICHELLE DR. P.O. BOX 2068 Tustin, CA 92781 -2068 |
| Contact | Timothy W Capehart |
| Correspondent | Timothy W Capehart TOSHIBA AMERICA MEDICAL SYSTEMS, INC. 2441 MICHELLE DR. P.O. BOX 2068 Tustin, CA 92781 -2068 |
| Product Code | IXR |
| CFR Regulation Number | 892.1980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-19 |
| Decision Date | 1992-09-04 |