Cleared Traditional

HESTIA

K243420 · Genoray Co., Ltd. · Radiology
Jul 2025
Decision
255d
Days
Class 2
Risk

About This 510(k) Submission

K243420 is an FDA 510(k) clearance for the HESTIA, 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 review panel. Regulated under 21 CFR 892.1715.

Submission Details

510(k) Number K243420 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code MUE — Full Field Digital, System, X-ray, Mammographic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1715