Cleared Traditional

Aorta-CAD (K213353) - FDA 510(k) Clearance

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

K213353 · Imagen Technologies, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

Device Classification

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 K213353.
DTX Studio Clinic 3.0
K221921 · Nobel Biocare AB · Mar 2023
Overjet Caries Assist
K222746 · Overjet, Inc. · Mar 2023
Overjet Calculus Assist
K220928 · Overjet, Inc. · Dec 2022
Overjet Caries Assist
K212519 · Overjet, Inc. · May 2022
Videa Caries Assist
K213795 · Videahealth, Inc. · Apr 2022
Second Opinion
K210365 · Pearl, Inc. · Mar 2022