Chest-CAD

FDA 510(k) K210666 · Imagen Technologies, Inc.

Substantially Equivalent

510(k) numberK210666

Submission

Device name
Chest-CAD
Applicant
Imagen Technologies, Inc.
New York, NY, US
Received
March 5, 2021
Decision date
July 20, 2021
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MYN – Analyzer, Medical Image
Device class
Class II (moderate risk)
Regulation
21 CFR 892.2070
Specialty
Radiology

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

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Questions and answers

When was Chest-CAD cleared by the FDA?

Chest-CAD (K210666) received a 510(k) decision of Substantially Equivalent on July 20, 2021, 137 days after the submission was received.

What is the product code of K210666?

The FDA product code is MYN – Analyzer, Medical Image, a Class II (moderate risk) device regulated under 21 CFR 892.2070.