Cleared Special

BriefCase-Quantification

K241112 · Aidoc Medical , Ltd. · Radiology
May 2024
Decision
23d
Days
Class 2
Risk

About This 510(k) Submission

K241112 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 May 15, 2024, 23 days after receiving the submission on April 22, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K241112 FDA.gov
FDA Decision Cleared SESE
Date Received April 22, 2024
Decision Date May 15, 2024
Days to Decision 23 days
Submission Type Special
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.