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510(k) K141672

DIGIARC 100AU+ by Beijing East Whale Imaging Technology Co., Ltd. — Product Code OXO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 31, 2014
Date Received
June 23, 2014
Clearance Type
Special
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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