K200424 is an FDA 510(k) clearance for the Giotto Class (Models - 3000X-YY and 4000X-YY). This device is classified as a Full Field Digital, System, X-ray, Mammographic (Class II - Special Controls, product code MUE).
Submitted by Ims Giotto S.P.A. (Sasso Marconi, IT). The FDA issued a Cleared decision on June 18, 2020, 119 days after receiving the submission on February 20, 2020.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1715.
| 510(k) Number | K200424 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 20, 2020 |
| Decision Date | June 18, 2020 |
| Days to Decision | 119 days |
| Submission Type | Special |
| Review Panel | Radiology (RA) |
| Summary | Statement |
| Product Code | MUE - Full Field Digital, System, X-ray, Mammographic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1715 |