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510(k) K232346

Digital Expert Access with Remote Scanning by Ge Healthcare — Product Code LNH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 27, 2023
Date Received
August 4, 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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