Cleared Traditional

K213353 - Aorta-CAD

K213353 is an FDA 510(k) clearance for Aorta-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 347-day FDA review.

K213353 · Imagen Technologies, Inc. · Radiology device
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Sep 2022
Decision
347d
Days
Class 2
Risk

K213353 is an FDA 510(k) clearance for the Aorta-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 September 20, 2022 after a review of 347 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K213353

510(k) Number K213353 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 08, 2021
Decision Date September 20, 2022
Days to Decision 347 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
240d slower than avg
Panel avg: 107d · This submission: 347d
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.

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All 36
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