K243420
- 510(k) number
- K243420
- Device name
- HESTIA
- Applicant
- Genoray Co., Ltd. KR
- Product code
- MUE — Full Field Digital, System, X-Ray, Mammographic
- Decision date
- 2025-07-17
- Date received
- 2024-11-04
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K243420.pdf
Official FDA record: K243420
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.