ImagenSPECT 3.0
K-Number: K201933 · 2020-08-11
ApplicantCardiovascular Imaging Technologies
Decision Date2020-08-11
Product CodeKPS
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
ImagenSPECT 3.0 is a medical device manufactured by Cardiovascular Imaging Technologies. It received FDA 510(k) clearance on 2020-08-11 under approval number K201933. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ImagenSPECT 3.0?
ImagenSPECT 3.0 is a medical device that received FDA 510(k) clearance on 2020-08-11. It is manufactured by Cardiovascular Imaging Technologies. The 510(k) number is K201933.
When was ImagenSPECT 3.0 approved by the FDA?
ImagenSPECT 3.0 received FDA 510(k) clearance on 2020-08-11, under approval number K201933.
What company makes ImagenSPECT 3.0?
ImagenSPECT 3.0 is manufactured by Cardiovascular Imaging Technologies.
What is the FDA product code for ImagenSPECT 3.0?
The FDA product code for ImagenSPECT 3.0 is KPS.
Other Devices by Cardiovascular Imaging Technologies
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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.