Device Information

• Device Name: Ziehm Solo FD
• Manufacturer: Ziehm Imaging GmbH
• Regulation Number: 21 CFR 892.1650
• Regulatory Class: Class II
• Product Code: OWB, JAA, OXO
• 510(k) Number: K234109
• FDA Decision Date: January 26, 2024
• Common Name: Image-Intensified Fluoroscopic X-Ray System
• Medical Specialty: Radiology

Indications

The Ziehm Solo FD is intended to provide medical imaging for adults and pediatric populations. It uses pulsed and continuous fluoroscopic imaging to capture and display images for diagnostic, interventional, and surgical procedures. Clinical applications include, but are not limited to, pediatric, cholangiography, endoscopic, urologic, lithotripsy, orthopedic, neurologic, vascular, cardiac, angiographic, critical care, and emergency room procedures. The device does not support direct radiographic film exposures and is not intended for mammography or use near MRI systems.

Limitations

The device is not intended for use in performing mammography or near MRI systems.

Study Results

The Ziehm Solo FD has undergone verification and validation testing, complying with FDA requirements. The device meets relevant safety standards, including electrical safety and electromagnetic compatibility. No new tests were conducted on wireless features or image quality compared to the predicate device.

Regulatory Information

The Ziehm Solo FD was cleared based on its substantial equivalence to a legally marketed predicate device. The device complies with various federal performance standards for X-ray fluoroscopic equipment.

Manufacturer Information

• Manufacturer Name: Ziehm Imaging GmbH
• Manufacturer Address: Lina-Ammon-Strasse 10, Nuremberg, 90471, Germany
• Contact Person: Ms. Tsvetelina Milanova
• Contact Email: Zie-Regulatory@ziehm.com
• Contact Telephone: +4991166067581

Predicate Device Information

The Ziehm Solo FD was compared to the previously cleared Ziehm Solo FD (510(k) Number: K231669). The primary modification in the new version is an updated software release, incorporating an upgrade from Ubuntu 16.04 to Ubuntu 20.04.

Implications

The Ziehm Solo FD provides clinicians with a reliable tool for fluoroscopic imaging across various medical procedures. Compliance with regulatory standards ensures safety and effectiveness, making it a valuable asset in diagnostic and surgical environments.

References

Ziehm Solo FD. K234109. FDA summary link https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?id=K234109