Genesis X-Ray Fluoroscopic Image-Intensified System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K151485 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 X-Ray, Fluoroscopic, Image-Intensified System (Device Class II), designed for real-time radiographic and fluoroscopic imaging. It provides high-resolution visualization of internal structures, supporting diagnostic procedures in urology, gynecology, and endoscopic evaluations. The system accommodates both horizontal and vertical patient positioning for versatile clinical applications.
Used in physician offices and hospitals, the Genesis is a reusable medical device intended for sterile field applications. It operates under FDA 510(k) clearance (K151485) and adheres to 21 CFR 892.1650 regulations. The system is non-MRI-compatible and requires proper storage and maintenance to ensure operational integrity. Multiple model variants are registered under FEI numbers and registration numbers for regulatory tracking.
Frequently asked questions
What clinical specialties is the Genesis X-Ray, Fluoroscopic, Image-Intensified System primarily used for, and how does its design support those procedures?
The Genesis system is designed for real-time radiographic and fluoroscopic imaging, making it particularly useful in urology, gynecology, and endoscopic evaluations. Its high-resolution visualization capabilities allow clinicians to clearly observe internal structures during procedures, while the ability to accommodate both horizontal and vertical patient positioning enhances flexibility in these specialties.
Is the Genesis system reusable, and if so, what considerations should be taken for maintaining its sterility and operational integrity?
Yes, the Genesis is a reusable medical device intended for sterile field applications. To ensure sterility and operational integrity, it must be properly cleaned, disinfected, and maintained according to manufacturer guidelines. Since it is non-MRI-compatible, storage and handling should also avoid exposure to magnetic fields or environments that could compromise its functionality.
How many model variants of the Genesis system are registered, and what does this mean for purchasing or upgrading?
The Genesis system has multiple model variants, each tracked under distinct FEI (Facility Equipment Identifier) and registration numbers—over 100 are listed in regulatory records. This variety allows healthcare facilities to select a model that best fits their specific clinical needs, room dimensions, or workflow requirements, ensuring compatibility with their existing infrastructure.
What regulatory pathway was followed for the Genesis system’s FDA clearance, and what does this imply for its use in clinical settings?
The Genesis system received FDA clearance through a 510(k) submission, classified as Substantially Equivalent under the Radiology advisory committee (RA). This clearance confirms that the device meets FDA standards for safety and effectiveness, allowing its use in physician offices and hospitals for diagnostic procedures like those in urology, gynecology, and endoscopy. The clearance also adheres to 21 CFR 892.1650, ensuring compliance with regulatory requirements.
Can the Genesis system be used in an MRI environment, and if not, what precautions should be taken during storage and transport?
No, the Genesis system is explicitly non-MRI-compatible, meaning it should never be used in or near an MRI scanner. For storage and transport, it must be kept in a location free from electromagnetic interference, magnetic fields, or environments that could damage its components. Always follow manufacturer instructions to preserve functionality and patient safety.
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
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K151485 | Class II | Active |
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Manufacturer
- Manufacturer
- Dornier MedTech America, Inc.
Sources (1)
- FDA 510(k) K151485 24 fields · synced Oct 6, 2026