Ventripoint Medical System Plus (VMS+) 3.0

K191493

Ventripoint Diagnostics, Ltd. · cleared 2019-10-16 · product code LLZ · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.3)

“The VMS+ 3.0 is an adjunct to existing ultrasound imaging systems and is intended to record, analyze, store and retrieve digital ultrasound images for computerized 3-dimensional image processing.”

AlgorithmKnowledge-Based Reconstruction (KBR) algorithm that uses anatomic landmarks on 2D images to build an accurate 3D constructed shape mesh (defined by vertices, edges, and faces) to calculate volumes of heart chambers.

source quote (p.5)

“Using the Knowledge-Based Reconstruction (KBR) algorithm and capturing 2D ultrasound images at specific angles and locations to recreate the shape of a heart is the technological principle for both the subject and predicate devices. It is based on the use of the constructed heart information to calculate volumes of any one of the four chambers, either at end-diastolic and/or end-systolic. Knowledge-based reconstruction algorithm. Requires placement of anatomic landmarks on the 2D images. Landmarks are then used to build an accurate 3D constructed shape mesh (defined by vertices, edges, and faces).”

Adaptive (vs locked)FDA source did not state this

PCCPFDA source did not state this

Cybersecurity addressedFDA source did not state this

Validation studies (4)

Bench

sample size not stated

endpoints: cytotoxicity; sensitization; irritation of intracutaneous reactivity

standards: ISO 10993-1

Bench

sample size not stated

endpoints: safety and essential performance; electromagnetic compatibility

standards: IEC 60601-1, IEC 60601-1-2

Bench

sample size not stated

endpoints: performs as intended; specifications conform to user needs and intended uses; requirements implemented can be consistently fulfilled

standards: FDA's Guidance for Industry and FDA Staff, “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."

Bench

sample size not stated

endpoints: substantially equivalent in performance specifications to the previously cleared reference device; delivers volume measurements that are equivalent in accuracy when compared with volumes obtained using the legally marketed VMS+

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

recalls in product code, 24mo

295

MAUDE reports in code, 12mo

+683%

vs code's own 3-yr baseline

drift signals on this device

re_clearance
The FDA AI/ML device list shows a newer 510(k) K241222 (decision 2025-02-26) from Ventripoint Diagnostics Ltd. for a matching device line ("Ventripoint Medical System Plus (VMS+) 4.0") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K241222
adverse_event_inflection
MAUDE adverse-event reports for product code LLZ: 295 in the 12 months ending 2026-06, vs a 37.7/12mo average over the prior 3 windows (+683%). Code-level count — reports are not attributed to this specific device.
first seen 2026-07-08 · openFDA /device/event.json count=date_received product_code=LLZ
recall_reason_pattern
Software/algorithm-related recall in product code LLZ (GE Medical Systems SCS, initiated 2026-05-08): "GE HealthCare has become aware of a context synchronization issue in AW Server 3.2 ext. 6.5. When a user selects a patient or exam in the AW Server Web Client worklist and launches" Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:99042
recall_reason_pattern
Software/algorithm-related recall in product code LLZ (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands, initiated 2026-03-05): "Potential that mis-ordered frames in Vue Motion during dynamic cine runs may cause images frames to display out of sequence." Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:98520
recall_reason_pattern
Software/algorithm-related recall in product code LLZ (GE Medical Systems, LLC, initiated 2026-01-30): "There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on the local client workstation, w" Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:98428
recall_reason_pattern
Software/algorithm-related recall in product code LLZ (Focalyx Technologies, LLC., initiated 2025-12-23): "Software device that is an accessory for image-guided interventional and diagnostic procedures involving prostate has accessories that may not function properly with Windows 10, wh" Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:98137
…and 21 more.

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).