Cleared Traditional

qXR-Detect

K251934 · Qure.Ai Technologies · Radiology
Jan 2026
Decision
206d
Days
Class 2
Risk

About This 510(k) Submission

K251934 is an FDA 510(k) clearance for the qXR-Detect, a Analyzer, Medical Image (Class II — Special Controls, product code MYN), submitted by Qure.Ai Technologies (Mumbai, IN). The FDA issued a Cleared decision on January 16, 2026, 206 days after receiving the submission on June 24, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2070.

Submission Details

510(k) Number K251934 FDA.gov
FDA Decision Cleared SESE
Date Received June 24, 2025
Decision Date January 16, 2026
Days to Decision 206 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code MYN — Analyzer, Medical Image
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.2070
Definition For Information On The Myn Device, Please See: Https://www.federalregister.gov/documents/2020/01/22/2020-00494/radiology-devices-reclassification-of-medical-image-analyzers