Cleared Traditional

K241925 - VitruvianScan (v1.0)

K241925 is the FDA 510(k) clearance for VitruvianScan (v1.0) by Perspectum, Ltd.. It is a Class 2 Radiology device (product code LNH) cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K241925 · Perspectum, Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2024
Decision
93d
Days
Class 2
Risk

K241925 is an FDA 510(k) clearance for the VitruvianScan (v1.0). Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Perspectum, Ltd. (Oxford, GB). The FDA issued a Cleared decision on October 2, 2024 after a review of 93 days - within the typical 510(k) review window.

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, Ltd. devices

Submission Details

510(k) Number K241925 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 107d · This submission: 93d
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

All 812
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K241925.
SyMRI
K242524 · Syntheticmr AB (Publ.) · Dec 2024
MROpen Evo (03-2000-00)
K242258 · Asg Superconductors S.P.A. · Nov 2024
SIGNA MAGNUS
K241242 · Ge Medical Systems, LLC · Oct 2024
MuscleView
K241331 · Springbok, Inc. · Oct 2024
MyoStrain (6.0)
K241607 · Myocardial Solutions, Inc. · Aug 2024
Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR
K241496 · Canon Medical Systems Corporation · Aug 2024