CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield (ROI Assembly)— 510(k) K191713

Name: FDA 510(k) clearance K191713
Creator: U.S. Food and Drug Administration
Published: 2019-10-04

Substantially Equivalent

Omega Medical Imaging, LLC

FDA 510(k) clearance K191713 for CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield (ROI Assembly), Substantially Equivalent on 2019-10-04. Applicant: Omega Medical Imaging, LLC. Device class: 2.

Clearance details

Applicant: Omega Medical Imaging, LLC
Product code: Code JAA
Device class: Class 2
Regulation: 21 CFR 892.1650
Advisory panel: Radiology
Date received: 2019-06-26
Decision date: 2019-10-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sanford, FL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code JAA

product code JAA

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.