Cleared Traditional

InferOperate Suite

K250237 · Beijing Infervision Healthcare Medical Technology Co., Ltd. · Radiology
Sep 2025
Decision
231d
Days
Class 2
Risk

About This 510(k) Submission

K250237 is an FDA 510(k) clearance for the InferOperate Suite, a Automated Radiological Image Processing Software (Class II — Special Controls, product code QIH), submitted by Beijing Infervision Healthcare Medical Technology Co., Ltd. (Beijing, CN). The FDA issued a Cleared decision on September 15, 2025, 231 days after receiving the submission on January 27, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K250237 FDA.gov
FDA Decision Cleared SESE
Date Received January 27, 2025
Decision Date September 15, 2025
Days to Decision 231 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.