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510(k) K190024

Smart-C by Turner Imaging Systems, Inc. — Product Code OXO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 2019
Date Received
January 7, 2019
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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