Cleared Traditional

MuscleView 2.0 (K251682) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K251682 · Springbok, Inc. (Dba Springbok Analytics) · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2025
Decision
102d
Days
Class 2
Risk

K251682 is an FDA 510(k) clearance for the MuscleView 2.0. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Springbok, Inc. (Dba Springbok Analytics) (Charlottesville, US). The FDA issued a Cleared decision on September 9, 2025 after a review of 102 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 Springbok, Inc. (Dba Springbok Analytics) devices

Submission Details

510(k) Number K251682 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 2025
Decision Date September 09, 2025
Days to Decision 102 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized Yes - Predetermined Change Control Plan authorized FDA has pre-authorized specific future modifications to this device, a pathway common in AI/SaMD devices.
Regulatory Context
Review time vs. panel average
5d faster than avg
Panel avg: 107d · This submission: 102d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. PCCP authorized - AI/SaMD pathway.

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 500
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K251682.
uMR 680
K252371 · Shanghai United Imaging Healthcare Co., Ltd. · Sep 2025
ECHELON Synergy
K251386 · Fujifilm Corporation · Sep 2025
SIGNA™ Sprint
K251399 · Ge Medical Systems, LLC · Sep 2025
Vista OS, Vista AI Scan, RTHawk
K251029 · Vista AI, Inc. · Aug 2025
InVision™ 3T Recharge Operating Suite
K252239 · Imris Imaging, Inc. · Aug 2025
uMR Jupiter
K250246 · Shanghai United Imaging Healthcare Co., Ltd. · Aug 2025