# Qure.Ai Technologies

- Location (FDA's records): Mumbai, IN
- FDA decisions: 9 (2020–2026): 9 510(k) clearances
- Product codes: QIH (4), MYN (2), QAS (2), QFM (1)
- 510(k) review time since 2016: median 144 days, against 128 for FDA's reviews in the same codes and years (5 of 9 faster)
- Predicates its devices cite: 10 (0 its own); citations of its devices by later devices: 6 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Imagen Technologies, Inc.: 1 (https://510kreport.com/company/imagen-technologies)
- Nines, Inc.: 1 (https://510kreport.com/company/nines)
- Philips Medical Systems Nederland B.V.: 1 (https://510kreport.com/company/philips-medical-systems-nederland)
- Ever Fortune.Ai, Co., Ltd.: 1 (https://510kreport.com/company/ever-fortune-ai)
- Samsung Electronics Co., Ltd.: 1 (https://510kreport.com/company/samsung-electronics)
- Icometrix NV: 1 (https://510kreport.com/company/icometrix)
- Viz. Ai, Inc.: 1 (https://510kreport.com/company/viz-ai)
- Lunit, Inc.: 1 (https://510kreport.com/company/lunit)

## Firms that cite its devices most
- Aidoc Medical, Ltd.: 1 (https://510kreport.com/company/aidoc-medical)
- Vuno, Inc.: 1 (https://510kreport.com/company/vuno)
- Ever Fortune.Ai, Co., Ltd.: 1 (https://510kreport.com/company/ever-fortune-ai)
- Viz. Ai, Inc.: 1 (https://510kreport.com/company/viz-ai)
- Ischemaview, Inc.: 1 (https://510kreport.com/company/ischemaview)
- Siemens Medical Solutions USA, Inc.: 1 (https://510kreport.com/company/siemens-medical-solutions-usa)

## Its most-cited devices
- K211222: qER-Quant (2021), cited by 4
- K230899: qXR-PTX-PE (2023), cited by 1
- K200921: qER (2020), cited by 1

## Recent decisions
- K251934: qXR-Detect (Jan 16, 2026)
- K251610: qER-CTA (v1.0) (Sep 8, 2025)
- K240740: qCT LN Quant (Aug 16, 2024)
- K231805: qXR-LN (Dec 22, 2023)
- K231149: qXR-CTR (Sep 22, 2023)
- K230899: qXR-PTX-PE (Aug 22, 2023)
- K212690: qXR-BT (Dec 21, 2021)
- K211222: qER-Quant (Jul 30, 2021)

Source page: https://510kreport.com/company/qure-ai-technologies