K812799 is an FDA 510(k) clearance for the DCATS. This device is classified as a System, Telethermographic, Infrared (Class III - Premarket Approval, product code IYM).
Submitted by Dorex, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 20, 1981, 14 days after receiving the submission on October 6, 1981.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 884.2980.
| 510(k) Number | K812799 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 06, 1981 |
| Decision Date | October 20, 1981 |
| Days to Decision | 14 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | — |
| Product Code | IYM — System, Telethermographic, Infrared |
| Device Class | Class III - Premarket Approval |
| CFR Regulation | 21 CFR 884.2980 |