Cleared Traditional

K190017 - LiverMultiScan (LMSv3)

K190017 is the FDA 510(k) clearance for LiverMultiScan (LMSv3) by Perspectum Diagnostics, Ltd.. It is a Class 2 Radiology device (product code LNH) cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K190017 · Perspectum Diagnostics, Ltd. · Radiology device
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Jun 2019
Decision
175d
Days
Class 2
Risk

K190017 is an FDA 510(k) clearance for the LiverMultiScan (LMSv3). Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Perspectum Diagnostics, Ltd. (Oxford, GB). The FDA issued a Cleared decision on June 27, 2019 after a review of 175 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 Diagnostics, Ltd. devices

Submission Details

510(k) Number K190017 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 2019
Decision Date June 27, 2019
Days to Decision 175 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
68d slower than avg
Panel avg: 107d · This submission: 175d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.

Regulatory Peers - LNH System, Nuclear Magnetic Resonance Imaging

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