LiverMultiScan (v6.0)

K253413

Perspectum, Ltd. · cleared 2026-03-09 · product code LNH · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.5)
“LiverMultiScan is a standalone, post processing software as a medical device (SaMD).”
AlgorithmThe device quantifies liver tissue characteristics by producing three quantitative metrics: iron-corrected T1 (cT1), proton density fat fraction (PDFF), and liver iron concentration (LIC). The equations for LIC and cT1 calculations have been updated.
source quote (p.5)
“LiverMultiScan quantifies liver tissue characteristics from appropriately acquired MR datasets. It produces three quantitative metrics: iron-corrected T1 (cT1): which reflects fibro-inflammatory disease activity of the liver parenchyma, proton density fat fraction (PDFF): a measure of liver fat content, and liver iron concentration (LIC). Each of these metrics is standardized to a single reference, ensuring that reference ranges and clinical thresholds can be applied consistently, regardless of the MRI scanner used to acquire the measurement. cT1, PDFF and LIC all have a valid and well-founded correlation with liver histology and are associated with pathological processes such as fibro-inflammation, steatosis, and iron overload, respectively. However, the equation used to calculate the LIC value has changed in the subject device to align with the reference article. And, the cT1 calculation in the subject device is updated to account for T1 signal variations due to elevated fat in addition to what already existed in the predicate device.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (3)

Bench

sample size not stated

Reader study (MRMC)

sample size not stated

Retrospective clinical

sample size not stated

endpoints: substantial equivalence for corrected T1 measurements between MOLLI and NOLLI; repeatability of metrics for the same subject, on the same manufacturer and field strength, acquired on the same day; reproducibility of metrics for the same subject, on the same manufacturer but a different field strength, acquired on the same day; characterization of inter-operator variability; characterization of 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
2
drift signals on this device
  • 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/K253413