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510(k) K173612

Optima XR646 HD by Ge Hualun Medical Systems Co. , Ltd. — Product Code KPR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 11, 2017
Date Received
November 22, 2017
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Stationary
Device Class
Class II
Regulation Number
892.1680
Review Panel
RA
Submission Type

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