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FDA 510(k)

Aorta-CAD

K-Number: K213353 · 2022-09-20

ApplicantImagen Technologies, Inc.
Decision Date2022-09-20
Product CodeMYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Aorta-CAD is the device name listed in this FDA 510(k) record. The listed applicant is Imagen Technologies, Inc.. It received FDA 510(k) clearance on 2022-09-20 under 510(k) number K213353. The device is classified under product code MYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Aorta-CAD?

Aorta-CAD is a medical device that received FDA 510(k) clearance on 2022-09-20. The listed applicant is Imagen Technologies, Inc.. The 510(k) number is K213353.

When did Aorta-CAD receive FDA 510(k) clearance?

Aorta-CAD received FDA 510(k) clearance on 2022-09-20, under 510(k) number K213353.

Who is the listed applicant for Aorta-CAD?

The FDA 510(k) record lists Imagen Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Aorta-CAD?

The FDA product code for Aorta-CAD is MYN.

Other records listing Imagen Technologies, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K230085Lung-CADK223811Lung-CADK210666Chest-CADK193417FractureDetect (FX)

Related Devices (Code: MYN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261059Overjet Multi-Image Caries and Charting AssistOverjet, Inc.K260851Better Diagnostics Dental Assist (BDDA) Version 1.0Better Diagnostics AI Corp.K252953Velmeni for Dentists (V4D) Endo-PerioVelmeni, Inc.K251934qXR-DetectQure.Ai TechnologiesK252934DiagnocatDGNCT, LLCK253009DS Core DetectDentsply Sirona, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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