Cleared Traditional

K240554 - InferRead Lung CT.AI (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K240554 · Infervision Medical Technology Co., Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2025
Decision
443d
Days
Class 2
Risk

K240554 is an FDA 510(k) clearance for the InferRead Lung CT.AI. Classified as Lung Computed Tomography System, Computer-aided Detection (product code OEB), Class II - Special Controls.

Submitted by Infervision Medical Technology Co., Ltd. (Beijing, CN). The FDA issued a Cleared decision on May 16, 2025 after a review of 443 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2050 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Radiology submissions.

View all Infervision Medical Technology Co., Ltd. devices

Submission Details

510(k) Number K240554 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
336d slower than avg
Panel avg: 107d · This submission: 443d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OEB Lung Computed Tomography System, Computer-aided Detection
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - OEB Lung Computed Tomography System, Computer-aided Detection

All 18
Devices cleared under the same product code (OEB) and FDA review panel - the closest regulatory comparables to K240554.
AVIEW Lung Nodule CAD
K251203 · Coreline Soft Co., Ltd. · Dec 2025
V5med Lung AI
K242919 · V5med, Inc. · Mar 2025
syngo.CT Lung CAD (Version VD30)
K231157 · Siemens Healthcare GmbH · Jul 2023
AVIEW Lung Nodule CAD
K221592 · Coreline Soft Co., Ltd. · Feb 2023
ClearRead CT
K221612 · Riverain Technologies, Inc. · Dec 2022
syngo.CT Lung CAD
K203258 · Siemens Healthcare GmbH · Mar 2021