510(k) K243420
K243420 is an FDA 510(k) premarket notification submitted by Genoray Co., Ltd. for the device "HESTIA". The FDA issued a decision of Substantially Equivalent on July 17, 2025. The device falls under product code MUE (Full Field Digital, System, X-Ray, Mammographic), a Class II device regulated under 21 CFR 892.1715. Genoray Co., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 17, 2025
- Date Received
- November 4, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Full Field Digital, System, X-Ray, Mammographic
- Device Class
- Class II
- Regulation Number
- 892.1715
- Review Panel
- RA
- Submission Type