Cleared Traditional

K242467 - IQ-UIP (FDA 510(k) Clearance)

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

K242467 · Imbio, Inc. · Radiology device
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Dec 2024
Decision
121d
Days
Class 2
Risk

K242467 is an FDA 510(k) clearance for the IQ-UIP. Classified as Radiology Software For Referral Of Findings Related To Fibrotic Lung Disease. (product code QWO), Class II - Special Controls.

Submitted by Imbio, Inc. (Minneapolis, US). The FDA issued a Cleared decision on December 19, 2024 after a review of 121 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2085 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K242467 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 2024
Decision Date December 19, 2024
Days to Decision 121 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
14d slower than avg
Panel avg: 107d · This submission: 121d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QWO Radiology Software For Referral Of Findings Related To Fibrotic Lung Disease.
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2085
Definition Radiology Software For Referral Of Findings Related To Fibrotic Lung Disease Is A Prescription Image Processing Device That Analyzes Computed Tomography Images To Suggest The Presence Of Disease Or Of An Imaging Finding Suggestive Of Disease. The Output Of This Device Is Intended To Be Used As Adjunctive Information As Part Of A Referral Pathway In The Overall Diagnostic Assessment Process.
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.