FDA 510(k)

InVision Precision Cardiac Amyloid

K-Number: K243866 · 2025-05-21

ApplicantInVision Medical Technology Corporation

Decision Date2025-05-21

Product CodeSDJ

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

InVision Precision Cardiac Amyloid is the device name listed in this FDA 510(k) record. The listed applicant is InVision Medical Technology Corporation. It received FDA 510(k) clearance on 2025-05-21 under 510(k) 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. The listed applicant is InVision Medical Technology Corporation. The 510(k) number is K243866.

When did InVision Precision Cardiac Amyloid receive FDA 510(k) clearance?

InVision Precision Cardiac Amyloid received FDA 510(k) clearance on 2025-05-21, under 510(k) number K243866.

Who is the listed applicant for InVision Precision Cardiac Amyloid?

The FDA 510(k) record lists InVision Medical Technology Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for InVision Precision Cardiac Amyloid?

The FDA product code for InVision Precision Cardiac Amyloid is SDJ.

Other records listing InVision Medical Technology Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K232331InVision Precision LVEF (LVEF)

Related Devices (Code: SDJ)

K250151Us2.caEko.Ai Pte Ltd. D/B/A Us2.Ai K240860EchoGo Amyloidosis (1.0)Ultromics Limited

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.