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510(k) K241331

MuscleView by Springbok, Inc. — Product Code LNH

K241331 is an FDA 510(k) premarket notification submitted by Springbok, Inc. for the device "MuscleView". The FDA issued a decision of Substantially Equivalent on October 1, 2024. 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
October 1, 2024
Date Received
May 10, 2024
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