K202822 is an FDA 510(k) clearance for the Helianthus. This device is classified as a Full Field Digital, System, X-ray, Mammographic (Class II - Special Controls, product code MUE).
Submitted by Metaltronica Spa (Pomezia Rm, IT). The FDA issued a Cleared decision on December 15, 2021, 447 days after receiving the submission on September 24, 2020.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1715.
| 510(k) Number | K202822 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 24, 2020 |
| Decision Date | December 15, 2021 |
| Days to Decision | 447 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | MUE - Full Field Digital, System, X-ray, Mammographic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1715 |