Cleared Traditional

Hepatica v1 (Hepatica v1.0.0)

K203280 · Perspectum, Ltd. · Radiology
Jan 2021
Decision
67d
Days
Class 2
Risk

About This 510(k) Submission

K203280 is an FDA 510(k) clearance for the Hepatica v1 (Hepatica v1.0.0), 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 January 12, 2021, 67 days after receiving the submission on November 6, 2020. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1000.

Submission Details

510(k) Number K203280 FDA.gov
FDA Decision Cleared SESE
Date Received November 06, 2020
Decision Date January 12, 2021
Days to Decision 67 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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