FDA.reportPublic FDA data

510(k) K182834

Device
CS-series-FP With Optional ROI Accessory CA-100S
Applicant
Omega Medical Imaging, LLC
510(k) number
K182834
Product code
JAA  
Decision
Substantially Equivalent (SESE)
Decision date
2019-03-29
Date received
2018-10-09
Regulation
892.1650
Classification name
System, X-ray, Fluoroscopic, Image-intensified
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
John Newman Newman
Address
675 Hickman Cir. Sanford FL US 32771 32771

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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