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 a medical device manufactured by Imagen Technologies, Inc.. It received FDA 510(k) clearance on 2022-09-20 under approval 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. It is manufactured by Imagen Technologies, Inc.. The 510(k) number is K213353.
When was Aorta-CAD approved by the FDA?
Aorta-CAD received FDA 510(k) clearance on 2022-09-20, under approval number K213353.
What company makes Aorta-CAD?
Aorta-CAD is manufactured by Imagen Technologies, Inc..
What is the FDA product code for Aorta-CAD?
The FDA product code for Aorta-CAD is MYN.
Other Devices by Imagen Technologies, Inc.
Related Devices (Code: MYN)
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.