Qure.ai Technologies Inc
Church Street, NY, US
QURE.AI TECHNOLOGIES INC appears in FDA device records in Church Street, NY. FDA records list 9 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 9 510(k) clearances for Qure.ai Technologies Inc between 2020 and 2026. The busiest year on record is 2023, with 3. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2020 | 1 |
| 2021 | 2 |
| 2023 | 3 |
| 2024 | 1 |
| 2025 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K251934 | qXR-Detect | MYN | Substantially Equivalent | |
| K251610 | qER-CTA (v1.0) | QAS | Substantially Equivalent | |
| K240740 | qCT LN Quant | QIH | Substantially Equivalent | |
| K231805 | qXR-LN | MYN | Substantially Equivalent | |
| K231149 | qXR-CTR | QIH | Substantially Equivalent | |
| K230899 | qXR-PTX-PE | QFM | Substantially Equivalent | |
| K212690 | qXR-BT | QIH | Substantially Equivalent | |
| K211222 | qER-Quant | QIH | Substantially Equivalent | |
| K200921 | qER | QAS | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3017699515 | 3017699515 | QURE.AI TECHNOLOGIES INC | Suite 76J, One World Trade Center, New York, NY 10007, Church Street, NY 10007 US | 2026 | No device listings on this registration |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain