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510(k) K251682

MuscleView 2.0 by Springbok, Inc. (Dba Springbok Analytics) — Product Code LNH

K251682 is an FDA 510(k) premarket notification submitted by Springbok, Inc. (Dba Springbok Analytics) for the device "MuscleView 2.0". The FDA issued a decision of Substantially Equivalent on September 9, 2025. The device falls under product code LNH (System, Nuclear Magnetic Resonance Imaging), a Class II device regulated under 21 CFR 892.1000.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 9, 2025
Date Received
May 30, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Nuclear Magnetic Resonance Imaging
Device Class
Class II
Regulation Number
892.1000
Review Panel
RA
Submission Type

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FDA data resources