FDA applicant
Rayence Co., Ltd.
FDA records 39 decisions for Rayence Co., Ltd. (Hwaseong-Si, KR) from 2011 to 2026: 39 510(k) clearances. Most are in product codes MQB (Solid State X-Ray Imager (Flat Panel/Digital…) and MUH (System, X-Ray, Extraoral Source, Digital). Since 2016 its 510(k)s took a median of 28 days from receipt to decision, against 90 for FDA’s reviews in the same codes and years. Its devices cite 42 predicates, 26 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 Rayence Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2011.
Planning a device like Rayence Co., Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
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