InVision Precision Cardiac Amyloid
K-Number: K243866 · 2025-05-21
Decision Date2025-05-21
Product CodeSDJ
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
InVision Precision Cardiac Amyloid is a medical device manufactured by InVision Medical Technology Corporation. It received FDA 510(k) clearance on 2025-05-21 under approval number K243866. The device is classified under product code SDJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the InVision Precision Cardiac Amyloid?
InVision Precision Cardiac Amyloid is a medical device that received FDA 510(k) clearance on 2025-05-21. It is manufactured by InVision Medical Technology Corporation. The 510(k) number is K243866.
When was InVision Precision Cardiac Amyloid approved by the FDA?
InVision Precision Cardiac Amyloid received FDA 510(k) clearance on 2025-05-21, under approval number K243866.
What company makes InVision Precision Cardiac Amyloid?
InVision Precision Cardiac Amyloid is manufactured by InVision Medical Technology Corporation.
What is the FDA product code for InVision Precision Cardiac Amyloid?
The FDA product code for InVision Precision Cardiac Amyloid is SDJ.
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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.