FDA.report

510(k) K251610

Device
qER-CTA (v1.0)
Applicant
Qure.Ai Technologies
510(k) number
K251610
Product code
QAS
Decision
Substantially Equivalent (SESE)
Decision date
2025-09-08
Date received
2025-05-27
Regulation
892.2080
Classification name
Radiological Computer-Assisted Triage And Notification Software
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Rajesh Sukhija
Address
6th Floor, Wing E, Times Sq., Andheri- Kurla Rd., Marol, Andheri Mumbai IN 400059 400059

FDA Registration Numbers

Source Documents

510(k) summary PDF

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