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510(k) K043379

SHIMADZU SURGICAL MOBILE C-ARM IMAGING X-RAY SYSTEM, MODEL WHA-200 by Shimadzu Corp. — Product Code OXO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 17, 2005
Date Received
December 8, 2004
Clearance Type
Abbreviated
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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  • K072006 — DAR-9400F (August 31, 2007)
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