FDA applicant
Vieworks Co., Ltd.
FDA records 21 decisions for Vieworks Co., Ltd. (Anyang-Si, KR) from 2007 to 2026: 21 510(k) clearances. Most are in product codes MQB (Solid State X-Ray Imager (Flat Panel/Digital…) and LLZ (System, Image Processing, Radiological). Since 2016 its 510(k)s took a median of 128 days from receipt to decision, against 91 for FDA’s reviews in the same codes and years. Its devices cite 25 predicates, 16 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 Vieworks 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 Vieworks 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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