Cleared Traditional

LiverMultiScan (v6.0)

K253413 · Perspectum, Ltd. · Radiology
Mar 2026
Decision
159d
Days
Class 2
Risk

About This 510(k) Submission

K253413 is an FDA 510(k) clearance for the LiverMultiScan (v6.0), a System, Nuclear Magnetic Resonance Imaging (Class II — Special Controls, product code LNH), submitted by Perspectum, Ltd. (Oxford, GB). The FDA issued a Cleared decision on March 9, 2026, 159 days after receiving the submission on October 1, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1000.

Submission Details

510(k) Number K253413 FDA.gov
FDA Decision Cleared SESE
Date Received October 01, 2025
Decision Date March 09, 2026
Days to Decision 159 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code LNH — System, Nuclear Magnetic Resonance Imaging
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1000

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