← Back to catalogue

Genesis Image-Intensified X-Ray Fluoroscopic System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K122768

by Dornier MedTech America, Inc.

Identifiers

510(k) Number
K122768 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 Genesis is an image-intensified X-ray fluoroscopic system (Device Type: System, X-Ray, Fluoroscopic, Image-Intensified). It combines fluoroscopy and radiography to provide real-time and static imaging for diagnostic and procedural guidance, supporting a broad range of applications in urology and gynecology, including endoscopic and contrast studies. The system is designed to operate with patients in both horizontal and vertical positions, ensuring versatility in clinical settings.

This device is supplied as a reusable medical system and is intended for use in physician offices or hospitals. It requires appropriate regulatory compliance, including FDA 510(k) clearance (K122768) under the Radiology Advisory Committee. The system is classified as Class II and adheres to regulatory standards such as 21 CFR 892.1650. No specific sterility or MRI safety information is provided in the available data.

Frequently asked questions

What is the Genesis system used for in clinical settings?

The Genesis is an image-intensified X-ray fluoroscopic system designed to provide real-time and static imaging for diagnostic and procedural guidance. It supports a wide range of applications in urology and gynecology, including endoscopic and contrast studies. Its versatility allows it to operate with patients in both horizontal and vertical positions, making it suitable for various clinical environments like physician offices and hospitals.

Is the Genesis system reusable or single-use?

The Genesis is supplied as a reusable medical system. It is intended for repeated use in clinical settings, provided it undergoes proper maintenance, cleaning, and regulatory compliance procedures as outlined by the manufacturer and applicable standards.

What regulatory approval does the Genesis system hold?

The Genesis system holds FDA 510(k) clearance under the Radiology Advisory Committee, with clearance number K122768. It is classified as a Class II device and adheres to regulatory standards such as 21 CFR 892.1650. This clearance indicates that the device is deemed substantially equivalent to a legally marketed predicate device.

Does the Genesis system require any specific sterility measures?

The available data does not specify any particular sterility requirements for the Genesis system. Since it is a reusable device, standard infection control protocols, including cleaning and disinfection procedures, should be followed to ensure safe reuse in clinical settings.

What types of imaging does the Genesis system support?

The Genesis system supports both fluoroscopy and radiography. Fluoroscopy provides real-time moving images, which are useful for guiding procedures, while radiography offers static images for detailed diagnostic evaluation. This dual capability makes it highly versatile for urology and gynecology applications.

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: Genesis — Dornier MedTech Americas, Dornier MedTech - A Leading Urological Medical Device Company, GENESIS (K122768) — FDA 510 (k) | Innolitics

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Dornier MedTech America, Inc.

Sources (1)

  • FDA 510(k) K122768 24 fields · synced Oct 5, 2026