ZEN-7000 Fluoroscopic X-Ray System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K140041 FDA 510(k)
- FDA Product Code
- OWB 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 ZEN-7000 is an interventional fluoroscopic X-ray system designed for medical imaging procedures. It functions as a mobile fluoroscopy system to provide real-time radiographic visualization.
This device is authorized under FDA 510k clearance. It is intended for use in clinical settings as specified in the manufacturer's operational documentation.
Frequently asked questions
What is the primary function of the ZEN-7000?
The ZEN-7000 is an interventional fluoroscopic X-ray system designed to provide real-time radiographic visualization during medical imaging procedures.
Is the ZEN-7000 a mobile device?
Yes, the ZEN-7000 is designed as a mobile fluoroscopy system, allowing for flexibility in positioning within clinical environments for various imaging tasks.
What is the regulatory status of this device?
The ZEN-7000 is authorized under FDA 510k clearance, which indicates that the device has been reviewed and found to be substantially equivalent to legally marketed predicate devices.
Where can I find specific instructions for using this system?
The device is intended for use in clinical settings as specified in the manufacturer's operational documentation provided by Genoray Co., Ltd.
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: Genoray ZEN-7000 User's Manual | Manualzz, GENORAY, ZEN-7000 Fluoroscopic X-ray Manual | PDF | Radiography | X Ray - Scribd, (GENORAY) ZEN-7000 Users Manual Eng Ver 1.0 - Scribd
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K140041 | Class II | Active |
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Manufacturer
- Manufacturer
- Genoray Co., Ltd.
Sources (1)
- FDA 510(k) K140041 24 fields · synced Sep 21, 2026