LiverMultiScan

K202170

Perspectum LTD · cleared 2020-10-02 · product code LNH · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.4)
“LiverMultiScan is a standalone software device.”
AlgorithmThe device uses automated liver segmentation and region of interest (ROI) placements. Quantitative assessments include determination of triglyceride fat fraction (PDFF) using the LMS IDEAL method, T2* using DIXON or LMS MOST methods, and iron-corrected T1 (cT1) which is MOLLI-based.
source quote (p.3)
“LiverMultiScan (LMSv4) provides a number of tools, such as automated liver segmentation and region of interest (ROI) placements, to be used for the assessment of selected regions of an image. Quantitative assessments of selected regions include the determination of triglyceride fat fraction in the liver (PDFF), T2* and iron-corrected T1 (cT1) measurements. T2* may be optionally computed using the DIXON or LMS MOST methods. The MOLLI-based T1 measurement produced by LMSv4 is consistent with the literature-reported underestimation of ground truth T1 using MOLLI techniques”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedNo

Validation studies (2)

Bench

sample size not stated

endpoints: Accuracy of cT1 measurements; Accuracy of T2* measurements; Accuracy of IDEAL PDFF measurements; Precision of cT1 measurements; Precision of T2* measurements; Precision of IDEAL PDFF measurements

Retrospective clinical

sample size not stated

endpoints: Precision of LMSv4 measurements; Inter operator variability; Intra operator variability

Reported performance (6 observations)

accuracyas written: “cT1 (1.5T) Accuracy”stated without valueCI -189.5 to -35.11 ms
source quote (p.10)
“cT1 -189.5 to -35.11 ms”
accuracyas written: “T2* (1.5T) Accuracy”stated without valueCI -0.68 to 0.64 ms
source quote (p.10)
“T2* -0.68 to 0.64 ms”
accuracyas written: “IDEAL PDFF (1.5T) Accuracy”stated without valueCI -3.80 to 6.08%
source quote (p.10)
“IDEAL PDFF -3.80 to 6.08%”
accuracyas written: “cT1 (3T) Accuracy”stated without valueCI -187.0 to -19.12 ms
source quote (p.10)
“cT1 -187.0 to -19.12 ms”
accuracyas written: “T2* (3T) Accuracy”stated without valueCI -0.30 to 0.39 ms
source quote (p.10)
“T2* -0.30 to 0.39 ms”
accuracyas written: “IDEAL PDFF (3T) Accuracy”stated without valueCI -1.39 to 5.58%
source quote (p.10)
“IDEAL PDFF -1.39 to 5.58%”

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
4
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

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K213960 (decision 2022-09-06) from Perspectum for a matching device line ("LiverMultiScan v5 (LMSv5)") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K213960

  • 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); 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 Radiology 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/K202170