FDA applicant
Coreline Soft Co., Ltd.
FDA records 13 decisions for Coreline Soft Co., Ltd. (Seoul, KR) from 2018 to 2026: 13 510(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 175 days from receipt to decision, against 138 for FDA’s reviews in the same codes and years. Its devices cite 12 predicates, 7 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 Coreline Soft 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 2018.
Planning a device like Coreline Soft 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