Cleared Traditional

qXR-LN

K231805 · Qure.Ai Technologies · Radiology
Dec 2023
Decision
185d
Days
Class 2
Risk

About This 510(k) Submission

K231805 is an FDA 510(k) clearance for the qXR-LN, 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 December 22, 2023, 185 days after receiving the submission on June 20, 2023. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2070.

Submission Details

510(k) Number K231805 FDA.gov
FDA Decision Cleared SESE
Date Received June 20, 2023
Decision Date December 22, 2023
Days to Decision 185 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