Cardiovascular · 510(k) · 2025
InVision Precision Cardiac Amyloid
InVision Medical Technology Corporation. Cleared by FDA on 21 May 2025 under submission K243866, product code SDJ (adjunctive cardiac amyloidosis status indicator). What FDA's record says, in FDA's words.
Device record · K243866
- Device. InVision Precision Cardiac AmyloidDEVICE
- Company. InVision Medical Technology CorporationCOMPANY
- Decision. 21 May 2025, 510(k), substantially equivalent (traditional review); received 17 December 2024DECISION
- Panel. CardiovascularPANEL
- Product code. SDJ, Adjunctive Cardiac Amyloidosis Status IndicatorCODE
- Regulation. 21 CFR 870.2200, Class IIREG
- Source. FDA database entry · decision document (10 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
In Vision Precision Cardiac Amyloid is an automated machine learning-based decision support system, indicated as a screening tool for adult patients aged 65 years and over undergoing cardiovascular assessment using echocardiography. When utilized by an interpreting physician, this device provides information alerting the physician for referral to confirmatory investigations. In Vision Precision Cardiac Amyloid is indicated in adult populations over 65 years of age. Patient management decisions should not be made solely on the results of the In Vision Precision Cardiac Amyloid.
The product code's definition, from FDA's classification record. The adjunctive cardiac amyloidosis status indicator is a prescription device based on sensor technology or image data to provide information to an interpreting clinician in detecting cardiac amyloidosis. This device is intended for adjunctive use with other physical vital sign parameters and patient information and is not intended to independently direct therapy.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Modalities namedultrasound
- Mentionsadult patients
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 0 reports filed against devices carrying product code SDJ. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code SDJ, in Cardiovascular, from InVision Medical Technology Corporation, or cleared in 2025. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.