Cleared Traditional

BriefCase-Quantification

K242203 · Aidoc Medical , Ltd. · Radiology
Nov 2024
Decision
119d
Days
Class 2
Risk

About This 510(k) Submission

K242203 is an FDA 510(k) clearance for the BriefCase-Quantification, a Automated Radiological Image Processing Software (Class II — Special Controls, product code QIH), submitted by Aidoc Medical , Ltd. (Tell-Aviv, IL). The FDA issued a Cleared decision on November 22, 2024, 119 days after receiving the submission on July 26, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K242203 FDA.gov
FDA Decision Cleared SESE
Date Received July 26, 2024
Decision Date November 22, 2024
Days to Decision 119 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.