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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Nuclear Magnetic Resonance Imaging
510(k) Number K251682
Device Name MuscleView 2.0
Applicant
Springbok, Inc. (Dba Springbok Analytics)
110 Old Preston Ave.
Charlottesville,  VA  22902
Applicant Contact Scott Magargee
Correspondent
Springbok, Inc. (Dba Springbok Analytics)
110 Old Preston Ave.
Charlottesville,  VA  22902
Correspondent Contact Scott Magargee
Regulation Number892.1000
Classification Product Code
LNH  
Date Received05/30/2025
Decision Date 09/09/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 Yes
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