Ventripoint Medical System Plus (VMS+) 4.0
K241222Ventripoint Diagnostics Ltd. · cleared 2025-02-26 · product code QIH · Radiology
Premarket evidence — what FDA accepted
source quote (p.5)
“The Ventripoint VMS+ 4.0 System is a medical imaging device designed to assist clinicians in evaluating cardiac function through 3D reconstruction of heart chambers. It uses a Knowledge-Based Reconstruction (KBR) algorithm to recreate the heart's shape by capturing 2D ultrasound images at specific angles and referencing a database of MRI heart shape catalogs. The reconstructed 3D heart models are used to calculate volumes of any of the four chambers at end-diastolic and/or end-systolic phases. The software can also be installed on a separate workstation to import 3D datasets, MRI studies, and VMS+ studies. The VMS+ system includes a hardware stand with a computer, position sensors to track the 3D orientation of the ultrasound transducer and patient movement, and software to handle image capture, landmark placement, and reconstruction.”
source quote (p.5)
“It uses a Knowledge-Based Reconstruction (KBR) algorithm to recreate the heart's shape by capturing 2D ultrasound images at specific angles and referencing a database of MRI heart shape catalogs. An edge detection algorithm refines these points to match detected anatomical boundaries, ensuring model precision.”
source quote (p.7)
“Cybersecurity testing was performed as recommended by FDA's Guidance for Industry and FDA Staff, "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions". This included both internal cybersecurity validation and external penetration testing to ensure that any existing vulnerabilities were discovered and addressed, and that the device is cyber safe.”
Validation studies (2)
Bench
sample size not stated
endpoints: verify that the modified device was substantially equivalent in performance specifications to the previously cleared device; demonstrate that the system software performs as intended and all requirements are met
Standalone
n=160 images
endpoints: proportion of images for each software where all anatomical points within the image would be finalized, by the user, within its respective expert consensus region; user performance for final AI location using VMS+ 4.0 was at least as good as the predicate
Reported performance (0 observations)
FDA source did not state a quantitative performance metric — non-reporting is itself the signal.
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
Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). 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).