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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 K241331
Device Name MuscleView
Applicant
Springbok, Inc.
100 W. South Street, Suite 1E
Charlottesville,  VA  22902
Applicant Contact Scott Magargee
Correspondent
Springbok, Inc.
110 Old Preston Ave
Charlottesville,  VA  22902
Correspondent Contact Scott Magargee
Regulation Number892.1000
Classification Product Code
LNH  
Date Received05/10/2024
Decision Date 10/01/2024
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		 No
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