Cleared Traditional

K230085 - Lung-CAD

K230085 is an FDA 510(k) clearance for Lung-CAD, manufactured by Imagen Technologies, Inc.. The device is a Class 2 Radiology device with product code MYN cleared through the Traditional 510(k) pathway after a 265-day FDA review.

K230085 · Imagen Technologies, Inc. · Radiology device
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Oct 2023
Decision
265d
Days
Class 2
Risk

K230085 is an FDA 510(k) clearance for the Lung-CAD. Classified as Analyzer, Medical Image (product code MYN), Class II - Special Controls.

Submitted by Imagen Technologies, Inc. (New York, US). The FDA issued a Cleared decision on October 3, 2023 after a review of 265 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2070 - 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.

View all Imagen Technologies, Inc. devices

FDA 510(k) Submission Details - K230085

510(k) Number K230085 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 2023
Decision Date October 03, 2023
Days to Decision 265 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
158d slower than avg
Panel avg: 107d · This submission: 265d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MYN Device Classification - Class 2, Special Controls

Product Code MYN Analyzer, Medical Image
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2070
Definition For Information On The Myn Device, Please See: Https://www.federalregister.gov/documents/2020/01/22/2020-00494/radiology-devices-reclassification-of-medical-image-analyzers
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 - MYN Analyzer, Medical Image

All 36
Devices cleared under the same product code (MYN) and FDA review panel - the closest regulatory comparables to K230085.
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K231001 · Deeptek Medical Imaging Pvt, Ltd. · Oct 2023
Overjet Periapical Radiolucency Assist
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Lung-CAD
K223811 · Imagen Technologies, Inc. · Sep 2023
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K223133 · Imidex, Inc. · Aug 2023