FDA applicant
Oncosoft. Co., Ltd.
FDA records 2 decisions for Oncosoft. Co., Ltd. (Seoul, KR) from 2025 to 2026: 2 510(k) clearances. All are in product code QKB (Radiological Image Processing Software For…). Its devices cite 2 predicates, 1 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Oncosoft. Inc.,”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Oncosoft. 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 2025.
Planning a device like Oncosoft. 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