FDA applicant
DRTECH Corporation
FDA records 33 decisions for DRTECH Corporation (Seongnam-Si, KR) from 2008 to 2026: 33 510(k) clearances. Most are in product codes MQB (Solid State X-Ray Imager (Flat Panel/Digital…) and KPR (System, X-Ray, Stationary). Since 2016 its 510(k)s took a median of 99 days from receipt to decision, against 95 for FDA’s reviews in the same codes and years. Its devices cite 37 predicates, 23 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Drtech Corp.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided DRTECH Corporation’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 2008.
Planning a device like DRTECH Corporation’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