LVivo Seamless

K212466

DiA Imaging Analysis Ltd · cleared 2021-12-09 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.4)

“The LVivo Seamless is a standalone application that extends the LVivo Platform and runs offline on a server in a healthcare environment. The system accepts echo examinations in DICOM format that are sent from an Ultrasound device and automatically selects the adequate clips for EF and GLS evaluation. After the clip selection, the LVivo Seamless activates the FDA cleared LVivo EF and LVivo Strain modules which perform automatic evaluation. The results are sent to the PACS and are evaluated by a healthcare professional.”

Algorithmautomatically selects the adequate clips for EF and GLS evaluation. After the clip selection, the LVivo Seamless activates the FDA cleared LVivo EF and LVivo Strain modules which perform automatic evaluation.

source quote (p.4)

“The system accepts echo examinations in DICOM format that are sent from an Ultrasound device and automatically selects the adequate clips for EF and GLS evaluation. After the clip selection, the LVivo Seamless activates the FDA cleared LVivo EF and LVivo Strain modules which perform automatic evaluation.”

Adaptive (vs locked)FDA source did not state this

PCCPFDA source did not state this

Cybersecurity addressedFDA source did not state this

Validation studies (1)

Retrospective clinical

n=100 patients

endpoints: Correct identification of 4ch and 2ch and 3ch views in 90% of the examinations; Correlation of 80% between GLS by AFI and GLS by LVivo Seamless

Reported performance (3 observations)

sensitivity0.9

source quote (p.7)

“sensitivity and specificity and of 0.90, and 0.83 respectively.”

specificity0.83

source quote (p.7)

“sensitivity and specificity and of 0.90, and 0.83 respectively.”

accuracyas written: “Accuracy (Mean±1.96STD)”-1.4CI ± 3.93%

source quote (p.7)

“Accuracy (Mean±1.96STD) -1.4% ± 3.93%”

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

MAUDE reports in code, 12mo

—

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) K243331 (decision 2025-03-06) from DiA Imaging Analysis Ltd. for a matching device line ("LVivo Seamless") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K243331

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).