LiverMultiScan (v6.0)
K253413Perspectum, Ltd. · cleared 2026-03-09 · product code LNH · Radiology
Premarket evidence — what FDA accepted
source quote (p.5)
“LiverMultiScan is a standalone, post processing software as a medical device (SaMD).”
source quote (p.7)
“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”
Validation studies (2)
Bench
sample size not stated
endpoints: Phantom data used for testing accuracy of measurements
Reader study (MRMC)
sample size not stated
endpoints: Testing to reflect 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; Comparative testing between the operators’ results and the gold standard
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
- 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).