FDA applicant
Genoray Co., Ltd.
FDA records 24 decisions for Genoray Co., Ltd. (Seongnam-Si, KR) from 2007 to 2026: 24 510(k) clearances. Most are in product codes MUH (System, X-Ray, Extraoral Source, Digital) and OWB (Interventional Fluoroscopic X-Ray System). Since 2016 its 510(k)s took a median of 170 days from receipt to decision, against 105 for FDA’s reviews in the same codes and years. Its devices cite 31 predicates, 11 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Genoray Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Genoray Co., Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Genoray”
FDA records each applicant name separately; these may or may not be the same firm.