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510(k) K171755

CS-series-FP with MX CFP 3131 or MX CFP 2222 Option Radiographic/Fluoroscopy System by Omega Medical Imaging, LLC — Product Code OWB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 9, 2018
Date Received
June 13, 2017
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Interventional Fluoroscopic X-Ray System
Device Class
Class II
Regulation Number
892.1650
Review Panel
RA
Submission Type

Interventional fluoroscopy

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