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510(k) K121303

MOBILE C-ARM by Canon Inc. -Medical Equipment Group — Product Code OXO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 26, 2012
Date Received
May 1, 2012
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.

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