Cleared Traditional

qER-Quant

K211222 · Qure.Ai Technologies · Radiology
Jul 2021
Decision
98d
Days
Class 2
Risk

About This 510(k) Submission

K211222 is an FDA 510(k) clearance for the qER-Quant, a Automated Radiological Image Processing Software (Class II — Special Controls, product code QIH), submitted by Qure.Ai Technologies (Mumbai, IN). The FDA issued a Cleared decision on July 30, 2021, 98 days after receiving the submission on April 23, 2021. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K211222 FDA.gov
FDA Decision Cleared SESE
Date Received April 23, 2021
Decision Date July 30, 2021
Days to Decision 98 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code QIH — Automated Radiological Image Processing Software
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.2050
Definition To Provide Automated Radiological Image Processing And Analysis Tools. Software Implementing Artificial Intelligence Including Nonadaptive Machine Learning Algorithms Trained With Clinical And/or Artificial Data. In These Devices, The Algorithm Training Data Typically Impacts Device Performance. Adaptive Ai Algorithms Are Not Within Scope Of This Product Code.