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510(k) K163429

B6 by Beijing East Whale Imaging Technology Co., Ltd. — Product Code OXO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 4, 2017
Date Received
December 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.

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  • K141672 — DIGIARC 100AU+ (July 31, 2014)
  • K131423 — G-ARM MULTISCAN SYSTEM (November 7, 2013)

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