InVision Precision Cardiac Amyloid

K243866

InVision Medical Technology Corporation · cleared 2025-05-21 · product code SDJ · Cardiovascular

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.5)
“The InVision Precision Cardiac Amyloid (InVision PCA) is a Software as a Medical Device (SaMD) machine-learning screening algorithm to identify high suspicion of cardiac amyloidosis from routinely obtained echocardiogram videos.”
Algorithmmachine-learning screening algorithm
source quote (p.5)
“The InVision Precision Cardiac Amyloid (InVision PCA) is a Software as a Medical Device (SaMD) machine-learning screening algorithm to identify high suspicion of cardiac amyloidosis from routinely obtained echocardiogram videos. The InVision PCA algorithm uses a machine learning process to identify the presence of cardiac amyloidosis.”
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedYes
source quote (p.9)
“Cybersecurity testing - including Dynamic Code Analysis, Vulnerability Scanning, Fuzz Testing, and Penetration Testing - was conducted to evaluate the security of the device. There were no vulnerabilities identified, demonstrating that the InVision PCA's cybersecurity controls are effective and that there are no new cybersecurity-related risks for the InVision PCA.”

Validation studies (2)

Retrospective clinical

n=1,221 cases · 3 site(s)

endpoints: sensitivity; specificity

standards: IEC 62304, ISO 14971

Bench

sample size not stated

endpoints: Technical validation; numerical stability; regression testing

Reported performance (4 observations)

sensitivity0.607
source quote (p.8)
“The validation study met all its predefined endpoints, demonstrating a sensitivity of 0.607 and a specificity of 0.990.”
specificity0.99
source quote (p.8)
“The validation study met all its predefined endpoints, demonstrating a sensitivity of 0.607 and a specificity of 0.990.”
ppvas written: “PPV (0.5% prevalence)”0.237
source quote (p.8)
“PPV and NPV at various prevalences based on the device's sensitivity (Se) and specificity (Sp).”
npvas written: “NPV (0.5% prevalence)”0.998
source quote (p.8)
“PPV and NPV at various prevalences based on the device's sensitivity (Se) and specificity (Sp).”

Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.

Predicate network

Postmarket — what happened after clearance

0
recalls in product code, 24mo
0
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
0
drift signals on this device

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.

Reimbursement — how devices like this got paid

Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Cardiovascular panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K243866