FDA applicant
Envisionit Deepai, Ltd.
FDA records 1 decision for Envisionit Deepai, Ltd. (Cobham, GB) in 2024: 1 510(k) clearance. All are in product code QFM (Radiological Computer-Assisted Prioritization…). Its devices cite 1 predicate, 0 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 Envisionit Deepai, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2024.
Planning a device like Envisionit Deepai, 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