Device Information
The Ziehm Vision FD is a mobile fluoroscopic imaging system. It features a C-shaped support structure with a high-voltage generator and a flat-panel image receptor. This device uses four manual axes and one motorized axis for precise imaging. It also includes an optional wireless footswitch for flexible operation and supports peripheral devices like external monitors, printers, and image storage devices.
Indications
The Ziehm Vision FD is used for imaging during diagnostic, interventional, and surgical procedures. It is particularly suited for complex anatomical structures in various specializations such as vascular, cardiac, and orthopedic surgeries. This device is not suitable for mammography or use near MRI systems.
Ziehm Vision FD Intended Use
This system is intended for medical professionals to use fluoroscopic imaging during various diagnostic and surgical procedures. It is designed to visualize complex anatomical structures in several specialties, including cardiology, urology, and orthopedics.
Availability
- Prescription Use: This device is available by prescription only.
Study Results
- Nonclinical and Safety Testing: This system complies with electrical safety (ANSI/AAMI ES60601-1) and electromagnetic compatibility (IEC 60601-1-2). It also meets FDA requirements for X-ray fluoroscopic equipment (21 CFR 1020.30-32). The system’s software and cybersecurity have been upgraded for better performance.
Regulatory Information
- Regulation Number: 21 CFR 892.1650
- Regulatory Class: Class II
- Product Codes: OWB, JAA
- 510(k) Number: K240020
- Other Applicable Regulations: The device complies with IEC 60601-1-3, IEC 60601-2-43, and IEC 60601-2-54 standards.
Manufacturer Information
- Name: Ziehm Imaging GmbH
- Address: Lina-Ammon-Strasse 10, Nuremberg, 90471, Germany
- Contact Person: Tsvetelina Milanova
Predicate Device Information
- Predicate Device Name: Ziehm Vision FD
- 510(k) Number: K231700
- Predicate Classification: Primary predicate
- Differences: The current device includes software updates, transitioning from Ubuntu 16.04 to 20.04, improving cybersecurity and overall system performance.
Implications
This system provides high-quality imaging for various surgical and diagnostic uses. Its mobile design and enhanced software allow for more flexible and safer imaging in complex procedures.
References
- Ziehm Vision FD. K240020. FDA summary link: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?id=K240020
- Manufacturer website page: https://www.ziehm.com.
- https://www.ziehm.com/en/products/ziehm-vision-fd/
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