Cleared Traditional

qCT LN Quant

K240740 · Qure.Ai Technologies · Radiology
Aug 2024
Decision
151d
Days
Class 2
Risk

About This 510(k) Submission

K240740 is an FDA 510(k) clearance for the qCT LN 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 August 16, 2024, 151 days after receiving the submission on March 18, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K240740 FDA.gov
FDA Decision Cleared SESE
Date Received March 18, 2024
Decision Date August 16, 2024
Days to Decision 151 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.