K923584 is an FDA 510(k) clearance for the THERAPAX DXT 300 SERIES 3. This device is classified as a System, Therapeutic, X-ray (Class II - Special Controls, product code JAD).
Submitted by Oldelft Corp. of America (Fairfax, US). The FDA issued a Cleared decision on January 15, 1993, 179 days after receiving the submission on July 20, 1992.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5900.
| 510(k) Number | K923584 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 20, 1992 |
| Decision Date | January 15, 1993 |
| Days to Decision | 179 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Statement |
| Product Code | JAD — System, Therapeutic, X-ray |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.5900 |