CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield™ (ROI Assembly)

Omega Medical Imaging, LLC · K191713 · 2019-10-04

CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield™ (ROI Assembly) is an AI-enabled medical device from Omega Medical Imaging, LLC, listed by FDA (510(k), K191713) with a decision date of 2019-10-04. Review panel: Radiology.

FDA submission numberK191713
Pathway510(k)
CompanyOmega Medical Imaging, LLC
Review panel (specialty)Radiology
FDA decision date2019-10-04
DecisionSubstantially Equivalent
Product codeJAA
ClassificationSystem, X-Ray, Fluoroscopic, Image-Intensified
Device class2
Regulation number892.1650
Review time (calendar days)100
Applicant countryUS

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Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.