FDA applicant
Ray Co., Ltd.
FDA records 24 decisions for Ray Co., Ltd. (Hwaseong-Si, KR) from 2013 to 2026: 24 510(k) clearances. Most are in product codes OAS (X-Ray, Tomography, Computed, Dental) and MUH (System, X-Ray, Extraoral Source, Digital). Since 2016 its 510(k)s took a median of 56 days from receipt to decision, against 77 for FDA’s reviews in the same codes and years. Its devices cite 33 predicates, 22 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 Ray Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
3in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2013.
Planning a device like Ray 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) Report