Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Qure.Ai Technologies — Predicate Candidate Screening

9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

144 daysmedian FDA review time
206 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K251934qXR-DetectQure.Ai Technologies2026-01-162060
K251610qER-CTA (v1.0)Qure.Ai Technologies2025-09-081040
K240740qCT LN QuantQure.Ai Technologies2024-08-161510
K231805qXR-LNQure.Ai Technologies2023-12-221850
K231149qXR-CTRQure.Ai Technologies2023-09-221540
K230899qXR-PTX-PEQure.Ai Technologies2023-08-221440
K212690qXR-BTQure.Ai Technologies2021-12-211180
K211222qER-QuantQure.Ai Technologies2021-07-30980
K200921qERQure.Ai Technologies2020-06-17720

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda