LiverMultiScan v5 (LMSv5)

K213960

Perspectum · cleared 2022-09-06 · product code LNH · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.5)

“LiverMultiScan v5 (LMSv5) is a standalone software device.”

Algorithmautomatic processing functionality based on machine-learning to assist in the quantification of metrics during analysis, such as automatic artefact detection and automatic segmentation of the liver.

source quote (p.5)

“LiverMultiScan v5 includes automatic processing functionality based on machine-learning to assist in the quantification of metrics during analysis, such as automatic artefact detection and automatic segmentation of the liver.”

Adaptive (vs locked)FDA source did not state this

PCCPFDA source did not state this

Cybersecurity addressedYes

source quote (p.14)

“The hazard analysis identifies the potential software-related risks of using the device, and the mitigations implemented.”

Validation studies (2)

Bench

sample size not stated

endpoints: accuracy and precision of device measurements

Retrospective clinical

sample size not stated

endpoints: precision of LiverMultiScan v5 measurements across supported scanners; Inter and intra operator variability

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

100

recalls in product code, 24mo

510

MAUDE reports in code, 12mo

+5%

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) K253413 (decision 2026-03-09) from Perspectum, Ltd. for a matching device line ("LiverMultiScan (v6.0)") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K253413
recall_reason_pattern
Software/algorithm-related recall in product code LNH (Philips North America, initiated 2026-04-14): "The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction " Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:98779
recall_reason_pattern
Software/algorithm-related recall in product code LNH (Philips North America, initiated 2025-12-03): "The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS)." Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:98111

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).