Cleared Traditional

qER-CTA (v1.0)

K251610 · Qure.Ai Technologies · Radiology

Sep 2025

Decision

104d

Days

Class 2

Risk

About This 510(k) Submission

K251610 is an FDA 510(k) clearance for the qER-CTA (v1.0), a Radiological Computer-assisted Triage And Notification Software (Class II — Special Controls, product code QAS), submitted by Qure.Ai Technologies (Mumbai, IN). The FDA issued a Cleared decision on September 8, 2025, 104 days after receiving the submission on May 27, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2080.

Submission Details

510(k) Number	K251610 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 27, 2025
Decision Date	September 08, 2025
Days to Decision	104 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF

Device Classification

Product Code	QAS — Radiological Computer-assisted Triage And Notification Software
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 892.2080
Definition	Radiological Computer-assisted Triage And Notification Software Is An Image Processing Device Intended To Aid In Prioritization And Triage Of Time Sensitive Patient Detection And Diagnosis Based On The Analysis Of Medical Images Acquired From Radiological Signal Acquisition Systems. The Device Identifies Or Prioritizes Time Sensitive Imaging For Review By Prespecified Clinical Users Based On Software-based Image Analysis But Does Not Provide Information From The Image Analysis Other Than Triage And Notification .