FDA applicant
Dia Imaging Analysis, Ltd.
FDA records 10 decisions for Dia Imaging Analysis, Ltd. (Beer-Sheva, IL) from 2020 to 2025: 10 510(k) clearances. All are in product code QIH (Automated Radiological Image Processing Software). Since 2016 its 510(k)s took a median of 126 days from receipt to decision, against 145 for FDA’s reviews in the same codes and years. Its devices cite 10 predicates, 9 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 Dia Imaging Analysis, 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 2020.
Planning a device like Dia Imaging Analysis, 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