Cleared Traditional

QP-Brain?

K232231 · Quibim S.L. · Radiology
Dec 2023
Decision
139d
Days
Class 2
Risk

About This 510(k) Submission

K232231 is an FDA 510(k) clearance for the QP-Brain?, a Automated Radiological Image Processing Software (Class II — Special Controls, product code QIH), submitted by Quibim S.L. (Valencia, ES). The FDA issued a Cleared decision on December 13, 2023, 139 days after receiving the submission on July 27, 2023. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K232231 FDA.gov
FDA Decision Cleared SESE
Date Received July 27, 2023
Decision Date December 13, 2023
Days to Decision 139 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.