Data / Medical devices / India / Qure.ai Technologies Private Limited

Qure.ai Technologies Private Limited: FDA-registered device maker in Mumbai Maharashtra, India, 7 510(k) clearances

Name: Qure.ai Technologies Private Limited FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Qure.ai Technologies Private Limited is registered with the FDA (registration 3017840913) in Mumbai Maharashtra, India. It lists 5 device types. The FDA files 7 510(k) clearances under its listings, the newest dated August 16, 2024. Registered through 2026. FDA data exported November 3, 2026.

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FDA registration number: 3017840913
Address: 6th Floor, Wing E, Times Square Andheri-Kurla Road, Marol, Andheri (East), Mumbai Maharashtra, India, 400059
Owner or operator: QURE.AI TECHNOLOGIES PRIVATE LIMITED (10079068)
Roles: Manufacturer
First device listed: November 17, 2020
Registered through: 2026
Brand names listed: Qure App, Qure App v2, qCT LN Quant, qER, qER-Quant, qXR-BT, qXR-CTR, qXR-LN and more

Devices it lists

Device	Product code	Class	Role	Source
Analyzer, Medical Image	MYN	2	Manufacturer	accessdata.fda.gov
Automated Radiological Image Processing Software	QIH	2	Manufacturer	accessdata.fda.gov
Radiological Computer-Assisted Prioritization Software For Lesions	QFM	2	Manufacturer	accessdata.fda.gov
Radiological Computer-Assisted Triage And Notification Software	QAS	2	Manufacturer	accessdata.fda.gov
System, Digital Image Communications, Radiological	LMD	1	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
August 16, 2024	K240740	qCT LN Quant	QIH	Substantially Equivalent	Qure.Ai Technologies	accessdata.fda.gov
December 22, 2023	K231805	qXR-LN	MYN	Substantially Equivalent	Qure.Ai Technologies	accessdata.fda.gov
September 22, 2023	K231149	qXR-CTR	QIH	Substantially Equivalent	Qure.Ai Technologies	accessdata.fda.gov
August 22, 2023	K230899	qXR-PTX-PE	QFM	Substantially Equivalent	Qure.Ai Technologies	accessdata.fda.gov
December 21, 2021	K212690	qXR-BT	QIH	Substantially Equivalent	Qure.Ai Technologies	accessdata.fda.gov
July 30, 2021	K211222	qER-Quant	QIH	Substantially Equivalent	Qure.Ai Technologies	accessdata.fda.gov
June 17, 2020	K200921	qER	QAS	Substantially Equivalent	Qure.Ai Technologies	accessdata.fda.gov

Compare with other makers

Updated August 16, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.