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510(k) K172869

Discovery XR656 HD by Ge Hualun Medical Systems Co. , Ltd. — Product Code KPR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 20, 2017
Date Received
September 20, 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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  • K182626 — OEC One (November 16, 2018)
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