K203509 is an FDA 510(k) clearance for the SMART FINDER. This device is classified as a System, X-ray, Mammographic (Class II - Special Controls, product code IZH).
Submitted by Ims Giotto S.P.A. (Sasso Marconi, IT). The FDA issued a Cleared decision on July 14, 2021, 226 days after receiving the submission on November 30, 2020.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1710.
| 510(k) Number | K203509 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 30, 2020 |
| Decision Date | July 14, 2021 |
| Days to Decision | 226 days |
| Submission Type | Special |
| Review Panel | Radiology (RA) |
| Summary | Statement |
| Product Code | IZH - System, X-ray, Mammographic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1710 |