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510(k) K232644

neuro42 MRI System by Neuro42, Inc. — Product Code LNH

K232644 is an FDA 510(k) premarket notification submitted by Neuro42, Inc. for the device "neuro42 MRI System". The FDA issued a decision of Substantially Equivalent on February 8, 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
February 8, 2024
Date Received
August 30, 2023
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