Cleared Traditional

LiverMultiScan

K202170 · Perspectum, Ltd. · Radiology
Oct 2020
Decision
60d
Days
Class 2
Risk

About This 510(k) Submission

K202170 is an FDA 510(k) clearance for the LiverMultiScan, 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 October 2, 2020, 60 days after receiving the submission on August 3, 2020. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1000.

Submission Details

510(k) Number K202170 FDA.gov
FDA Decision Cleared SESE
Date Received August 03, 2020
Decision Date October 02, 2020
Days to Decision 60 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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