Cleared Traditional

K213960 - LiverMultiScan v5 (LMSv5)

K213960 is an FDA 510(k) clearance for LiverMultiScan v5 (LMSv5), manufactured by Perspectum. The device is a Class 2 Radiology device with product code LNH cleared through the Traditional 510(k) pathway after a 263-day FDA review.

K213960 · Perspectum · Radiology device
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Sep 2022
Decision
263d
Days
Class 2
Risk

K213960 is an FDA 510(k) clearance for the LiverMultiScan v5 (LMSv5). Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Perspectum (Oxford, GB). The FDA issued a Cleared decision on September 6, 2022 after a review of 263 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1000 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Perspectum devices

FDA 510(k) Submission Details - K213960

510(k) Number K213960 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 2021
Decision Date September 06, 2022
Days to Decision 263 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
156d slower than avg
Panel avg: 107d · This submission: 263d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LNH Device Classification - Class 2, Special Controls

Product Code LNH System, Nuclear Magnetic Resonance Imaging
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1000
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

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All 840
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