K212965 is an FDA 510(k) clearance for the Smile-100 System. This device is classified as a System, Telethermographic (adjunctive Use) (Class I - General Controls, product code LHQ).
Submitted by Niramai Health Analytix Private Limited (Bangalore, IN). The FDA issued a Cleared decision on March 10, 2022, 175 days after receiving the submission on September 16, 2021.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 884.2980.
| 510(k) Number | K212965 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 16, 2021 |
| Decision Date | March 10, 2022 |
| Days to Decision | 175 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 |