K243420 is an FDA 510(k) clearance for the HESTIA. This device is classified as a Full Field Digital, System, X-ray, Mammographic (Class II - Special Controls, product code MUE).
Submitted by Genoray Co., Ltd. (Seongnam-Si, KR). The FDA issued a Cleared decision on July 17, 2025, 255 days after receiving the submission on November 4, 2024.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1715.
| 510(k) Number | K243420 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 04, 2024 |
| Decision Date | July 17, 2025 |
| Days to Decision | 255 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 |