Qure.Ai Technologies: 7 FDA AI clearances
Every 510(k) clearance held by Qure.Ai Technologies under the AI-associated product codes this registry tracks, from openFDA public records, refreshed weekly. Facts only; listing is not evaluation.
| Device | Decision date | Category |
|---|---|---|
| qER-CTA (v1.0) | 2025-09-08 | QAS |
| qCT LN Quant | 2024-08-16 | QIH |
| qXR-CTR | 2023-09-22 | QIH |
| qXR-PTX-PE | 2023-08-22 | QFM |
| qXR-BT | 2021-12-21 | QIH |
| qER-Quant | 2021-07-30 | QIH |
| qER | 2020-06-17 | QAS |
Sources linked on each entry. Coverage note: this lists clearances under tracked AI-associated codes only — the company may hold other clearances outside them. Work for Qure.Ai Technologies? The disclosure rows on your entries update free on submission of public links — start here.
Text link:
Badge:
The vendor due-diligence checklist (interactive, stores nothing) · the contract rider (paste-ready, CC BY) · the live clearance report (weekly, citable) · the record verifier.
One email each Monday: what changed in FDA AI clearances, in two minutes. Unsubscribe any time.
Going deeper? The Compliance & Regulatory AI Toolkit ($97) is the complete evaluation workbook, and HAI-OS keeps the governance record once a tool is deployed. Vendors: a verified profile puts your website, governance contact and sealed governance record on Qure.Ai Technologies’s registry page ($950/yr, human-reviewed).