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510(k) K231133

neo315 by Neoscan Solution GmbH — Product Code LNH

K231133 is an FDA 510(k) premarket notification submitted by Neoscan Solution GmbH for the device "neo315". The FDA issued a decision of Substantially Equivalent on July 22, 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
July 22, 2024
Date Received
April 21, 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