510(k) · Radiology

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

by Omega Medical Imaging, LLC

CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield™ (ROI Assembly) is an AI-enabled medical device from Omega Medical Imaging, LLC that the U.S. FDA cleared through 510(k) K191713 on October 4, 2019. Its lead review panel is Radiology and its primary product code is JAA (System, X-Ray, Fluoroscopic, Image-Intensified).

See also FDA-cleared AI radiology devices in 2019, all FDA AI clearances in 2019, top radiology AI devices.

Key facts

Submission numberK191713
Pathway510(k)
Date of final decision
Company (FDA list)Omega Medical Imaging, LLC
Lead review panelRadiology
Primary product codeJAA — System, X-Ray, Fluoroscopic, Image-Intensified
Applicant (openFDA)Omega Medical Imaging, LLC
Applicant locationSanford, FL, US
Device classClass 2
Regulation number21 CFR 892.1650
Decision codeSESE
Submission typeTraditional

Source: FDA AI-Enabled Medical Devices list and openFDA.

What this means

A 510(k) is a premarket submission showing the device is substantially equivalent to a legally marketed predicate device. A cleared 510(k) means FDA agreed with that equivalence. CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield™ (ROI Assembly) went through this pathway (K191713).

openFDA lists it as a Class 2 device under 21 CFR 892.1650. Class II devices are moderate risk and are subject to general and special controls.

Product code JAA covers 4 devices on the FDA AI list. By decision date, this device is #2 of 4 under that code. Omega Medical Imaging, LLC has 3 AI-enabled devices on the list, and the Radiology panel accounts for 1,230 in total.

Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.

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