Cleared Traditional

VitruvianScan (v1.0)

K241925 · Perspectum, Ltd. · Radiology
Oct 2024
Decision
93d
Days
Class 2
Risk

About This 510(k) Submission

K241925 is an FDA 510(k) clearance for the VitruvianScan (v1.0), 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 October 2, 2024, 93 days after receiving the submission on July 1, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1000.

Submission Details

510(k) Number K241925 FDA.gov
FDA Decision Cleared SESE
Date Received July 01, 2024
Decision Date October 02, 2024
Days to Decision 93 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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