K212412 is an FDA 510(k) clearance for the IRIS-XP. This device is classified as a System, Telethermographic (adjunctive Use) (Class I - General Controls, product code LHQ).
Submitted by Medicore Co., Ltd. (Seongnam-Si, KR). The FDA issued a Cleared decision on September 13, 2021, 41 days after receiving the submission on August 3, 2021.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 884.2980.
| 510(k) Number | K212412 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 03, 2021 |
| Decision Date | September 13, 2021 |
| Days to Decision | 41 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | LHQ - System, Telethermographic (adjunctive Use) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 884.2980 |