K251610

Substantially Equivalent

qER-CTA (v1.0)

Applicant: Qure.Ai Technologies
Product code: QAS
Advisory panel: Radiology
Date received: 2025-05-27
Decision date: 2025-09-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mumbai, IN

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.