Cleared Traditional

K251682 - MuscleView 2.0

K251682 is an FDA 510(k) clearance for MuscleView 2.0, manufactured by Springbok, Inc. (Dba Springbok Analytics). The device is a Class 2 Radiology device with product code LNH cleared through the Traditional 510(k) pathway after a 102-day FDA review.

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

FDA 510(k) Submission Details - K251682

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.

LNH Device Classification - Class 2, Special Controls

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 840
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