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510(k) K182834

CS-series-FP with Optional ROI Accessory CA-100S by Omega Medical Imaging, LLC — Product Code JAA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 29, 2019
Date Received
October 9, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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  • K062647 — E-VIEW FLUOROSCOPY SYSTEM, MODEL CS-50 (October 20, 2006)

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