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CS-series-FP with Optional ROI Accessory CA-100S

FDA 510(k)

Class II (US FDA 510(k))

510(k) K182834

by Omega Medical Imaging, LLC

Identifiers

510(k) Number
K182834 FDA 510(k)
FDA Product Code
JAA FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.1650 FDA 510(k)
Regulation Number
892.1650 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The device is a System, X-ray, Fluoroscopic, Image-intensified, designed for interventional X-ray procedures. It incorporates Artificial Intelligence to enhance image guidance and significantly reduce radiation exposure for both patients and medical staff.

It is supplied with an optional ROI Accessory CA-100S that provides automated region of interest management to control exposure. The system is classified as Class II under FDA 510(k) clearance K182834, with product code JAA and regulation number 892.1650.

Frequently asked questions

What is the CS-series-FP with Optional ROI Accessory CA-100S used for?

The CS-series-FP is designed for interventional X-ray procedures, using image-intensified fluoroscopy and artificial intelligence to enhance image guidance and reduce radiation exposure for patients and staff during clinical interventions.

How is the CS-series-FP system supplied and what does the optional CA-100S accessory do?

The system is supplied as a complete fluoroscopic unit with the optional CA-100S ROI Accessory, which provides automated region of interest management to dynamically control X-ray exposure based on the area of clinical focus.

Is the CS-series-FP with CA-100S accessory intended for single-use or reuse?

The CS-series-FP is a reusable system designed for repeated clinical use in interventional settings; the CA-100S ROI Accessory is also a reusable component that integrates with the system for automated exposure control.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: CS-series-FP with Optional ROI Accessory CA-100S (K182834) — FDA 510 (k ..., CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S ..., K182834 - CS-series-FP with Optional ROI Accessor...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Omega Medical Imaging, LLC

Sources (1)

  • FDA 510(k) K182834 24 fields · synced Oct 1, 2026