FDA applicant
Abyzr Co., Ltd.
FDA records 1 decision for Abyzr Co., Ltd. (Hwaseong-Si, KR) in 2015: 1 510(k) clearance. All are in product code MQB (Solid State X-Ray Imager (Flat Panel/Digital…). Its devices cite 1 predicate, 0 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 Abyzr Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2015
2015high 1 (2015) · low 0 (2016)2026
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2015.
Planning a device like Abyzr 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