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510(k) K210173

StarGuide by Ge Healthcare — Product Code KPS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 29, 2021
Date Received
January 22, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Tomography, Computed, Emission
Device Class
Class II
Regulation Number
892.1200
Review Panel
RA
Submission Type

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