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510(k) K170946

Skan-C Mobile C-Arm X-Ray System - 230V Variant, Skan-C Mobile C-Arm X-Ray System - 110V Variant by Skanray Technologies Private Limited — Product Code OXO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 24, 2017
Date Received
March 30, 2017
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 Skanray Technologies Private Limited

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