HESTIA
K-Number: K243420 · 2025-07-17
ApplicantGenoray Co., Ltd.
Decision Date2025-07-17
Product CodeMUE
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
HESTIA is a medical device manufactured by Genoray Co., Ltd.. It received FDA 510(k) clearance on 2025-07-17 under approval number K243420. The device is classified under product code MUE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the HESTIA?
HESTIA is a medical device that received FDA 510(k) clearance on 2025-07-17. It is manufactured by Genoray Co., Ltd.. The 510(k) number is K243420.
When was HESTIA approved by the FDA?
HESTIA received FDA 510(k) clearance on 2025-07-17, under approval number K243420.
What company makes HESTIA?
HESTIA is manufactured by Genoray Co., Ltd..
What is the FDA product code for HESTIA?
The FDA product code for HESTIA is MUE.
Other Devices by Genoray Co., Ltd.
Related Devices (Code: MUE)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.