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510(k) K160984

MultiScan G-Arm System by Beijing East Whale Imaging Technology Co., Ltd. — Product Code OXO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 20, 2016
Date Received
April 7, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Image-Intensified Fluoroscopic X-Ray System, Mobile
Device Class
Class II
Regulation Number
892.1650
Review Panel
RA
Submission Type

Fluoroscopy of the human body.

Other clearances by Beijing East Whale Imaging Technology Co., Ltd.

  • K163429 — B6 (January 4, 2017)
  • K160343 — SIGMA P5/ OMEGA P7/ LAMBDA P9 Portable Ultrasound Diagnostic Scanner (April 7, 2016)
  • K151280 — MultiScan G-Arm System (September 30, 2015)
  • K141672 — DIGIARC 100AU+ (July 31, 2014)
  • K131423 — G-ARM MULTISCAN SYSTEM (November 7, 2013)

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  • K250587 — Orthoscan TAU Mini C-Arm (July 2, 2025)
  • K243452 — Orthoscan VERSA Mini C-Arm (January 14, 2025)
  • K240828 — OEC One ASD (December 27, 2024)
  • K233669 — OEC 3D (March 28, 2024)
  • K213113 — Orthoscan Tau Mini C-Arm (October 21, 2021)
  • K203346 — OEC 3D (March 5, 2021)
  • K192819 — OEC Elite (November 8, 2019)