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510(k) K211312

Universal Viewer by Ge Healthcare — Product Code LLZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 21, 2021
Date Received
April 30, 2021
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Image Processing, Radiological
Device Class
Class II
Regulation Number
892.2050
Review Panel
RA
Submission Type

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