FDA applicant
Disior, Ltd.
FDA records 6 decisions for Disior, Ltd. (Helsinki Uusimaa, FI) from 2021 to 2026: 6 510(k) clearances. Most are in product codes QIH (Automated Radiological Image Processing Software) and LLZ (System, Image Processing, Radiological). Since 2016 its 510(k)s took a median of 106 days from receipt to decision, against 141 for FDA’s reviews in the same codes and years. Its devices cite 8 predicates, 5 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 Disior, 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 2021.
Planning a device like Disior, 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