FDA applicant
Ewoosoft Co., Ltd.
FDA records 31 decisions for Ewoosoft Co., Ltd. (Hwaseong-Si, KR) from 2013 to 2025: 31 510(k) clearances. Most are in product codes LLZ (System, Image Processing, Radiological) and QIH (Automated Radiological Image Processing Software). Since 2016 its 510(k)s took a median of 50 days from receipt to decision, against 115 for FDA’s reviews in the same codes and years. Its devices cite 32 predicates, 27 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 Ewoosoft 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 2013.
Planning a device like Ewoosoft 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