QURE.AI TECHNOLOGIES PRIVATE LIMITED

FDA Device Registration & Listing · Mumbai Maharashtra, IN · Registration 3017840913

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3017840913
FEI Number
3017840913
Entity Name
QURE.AI TECHNOLOGIES PRIVATE LIMITED
City/State/Country
Mumbai Maharashtra, IN
Establishment Address
6th Floor, Wing E, Times Square, Andheri-Kurla Road, Marol, Andheri (East),, Mumbai Maharashtra 400059, IN
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
QURE.AI TECHNOLOGIES PRIVATE LIMITED (Owner Number: 10079068)
Owner / Operator Contact Address
6th Floor, Wing E, Times Square, Andheri-Kurla Road, Marol, Andheri (East),, Mumbai, IN-MH 400059, IN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K230899
PMA Number
N/A

All Registered Proprietary Names

qER qXR-LN qCT LN Quant qXR-BT qXR-PTX-PE

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
QAS Radiological Computer-Assisted Triage And Notification Software Radiology Class 2 892.2080 2020-11-17
MYN Analyzer, Medical Image Radiology Class 2 892.2070 2024-05-30
QIH Automated Radiological Image Processing Software Radiology Class 2 892.2050 2024-11-27
QIH Automated Radiological Image Processing Software Radiology Class 2 892.2050 2022-05-30
QFM Radiological Computer-Assisted Prioritization Software For Lesions Radiology Class 2 892.2080 2023-10-09

Official Correspondent

Bunty Kundnani

US Agent Details

MARGARET VERNON Business: Biologics Consulting Email: contracts@biologicsconsulting.com Phone: (703) 7395695

Related Public Records

Same Entity

QURE.AI TECHNOLOGIES PRIVATE LIMITED
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K220709 Aidoc Medical , Ltd. BriefCase 2022-10-07
K242270 Orthofix Srl OrthoNext Platform System 2024-12-19
K261713 FUJIFILM Healthcare Americas Corporation Synapse PACS (7.6.0) 2026-06-18
K243647 FUJIFILM Healthcare Americas Corporation Synapse PACS (7.5) 2025-06-30
K190362 Zebra Medical Vision, Ltd. HealthPNX 2019-05-06

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017840913. Last updated year: 2026. Please use registration number 3017840913 when referencing this establishment in official correspondence.
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