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510(k) K191699

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 24, 2019
Date Received
June 25, 2019
Clearance Type
Traditional
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

Other clearances by Ge Hualun Medical Systems Co. , Ltd.

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  • K231892 — Definium Pace Select (September 12, 2023)
  • K182626 — OEC One (November 16, 2018)
  • K173612 — Optima XR646 HD (December 11, 2017)
  • K172700 — OEC One (November 9, 2017)
  • K172869 — Discovery XR656 HD (October 20, 2017)
  • K171800 — OEC Elite MiniView (July 12, 2017)

Other clearances for product code KPR

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  • K250738 — YSIO X.pree (July 31, 2025)
  • K242019 — GXR-Series Diagnostic X-Ray System (January 7, 2025)
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  • K242119 — INNOVISION-EXII (January 3, 2025)
  • K241068 — uDR 780i (November 1, 2024)