ImagenSPECT
K-Number: K152503 · 2016-01-25
ApplicantCardiovascular Imaging Technologies
Decision Date2016-01-25
Product CodeKPS
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
ImagenSPECT is a medical device manufactured by Cardiovascular Imaging Technologies. It received FDA 510(k) clearance on 2016-01-25 under approval number K152503. 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?
ImagenSPECT is a medical device that received FDA 510(k) clearance on 2016-01-25. It is manufactured by Cardiovascular Imaging Technologies. The 510(k) number is K152503.
When was ImagenSPECT approved by the FDA?
ImagenSPECT received FDA 510(k) clearance on 2016-01-25, under approval number K152503.
What company makes ImagenSPECT?
ImagenSPECT is manufactured by Cardiovascular Imaging Technologies.
What is the FDA product code for ImagenSPECT?
The FDA product code for ImagenSPECT is KPS.
Other Devices by Cardiovascular Imaging Technologies
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K161674QuantumCamDdd-Diagnostic A/S
K162337Symbia 6.5Siemens Medical Solutions USA, Inc.
K161574Discovery MIGe Medical Systems, LLC
K161631MAMMIGeneral Equipment For Medical Imaging
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.