Cleared Traditional

InferRead Lung CT.AI

K240554 · Infervision Medical Technology Co., Ltd. · Radiology
May 2025
Decision
443d
Days
Class 2
Risk

About This 510(k) Submission

K240554 is an FDA 510(k) clearance for the InferRead Lung CT.AI, a Lung Computed Tomography System, Computer-aided Detection (Class II — Special Controls, product code OEB), submitted by Infervision Medical Technology Co., Ltd. (Beijing, CN). The FDA issued a Cleared decision on May 16, 2025, 443 days after receiving the submission on February 28, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K240554 FDA.gov
FDA Decision Cleared SESE
Date Received February 28, 2024
Decision Date May 16, 2025
Days to Decision 443 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code OEB — Lung Computed Tomography System, Computer-aided Detection
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.2050
Definition To Assist Radiologists In The Review Of Multi-slice Computed Tomography (msct) Exams Of The Chest And Highlight Potential Nodules That The Radiologist Should Review. A Computer Aided Diagnosis, Lung Computed Tomography System Is A Class 3 Device Under Product Code Nrr.