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Ziehm 8000

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K190497

by Ziehm Imaging GmbH

Identifiers

510(k) Number
K190497 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 Ziehm 8000 is an Interventional Fluoroscopic X-Ray System, designed for real-time imaging during surgical and interventional procedures. It provides high-resolution fluoroscopy to support precise visualisation of anatomical structures and guide interventions such as orthopaedic, pain management, and urological procedures.

This mobile C-arm system is intended for intraoperative use, offering compact design and ergonomic controls for ease of positioning. Supplied as a reusable device, it requires adherence to standard infection control protocols. The system is classified as Class II under FDA regulations and has received FDA 510(k) clearance and MDD compliance. Multiple model variants are authorised, as indicated by the listed registration numbers.

Frequently asked questions

What types of surgical and interventional procedures can the Ziehm 8000 support with its high-resolution fluoroscopy?

The Ziehm 8000 is specifically designed to provide real-time imaging for precise visualization during orthopaedic, pain management, and urological procedures. Its high-resolution fluoroscopy capabilities make it suitable for guiding interventions where accurate anatomical visualization is critical, such as joint replacements, spinal interventions, or minimally invasive urological treatments.

Is the Ziehm 8000 a single-use or reusable device, and what infection control measures should be followed?

The Ziehm 8000 is a reusable interventional fluoroscopic system. Since it is not sterile out-of-the-box, strict adherence to standard infection control protocols is required between uses to ensure patient safety and device longevity.

How is the Ziehm 8000 supplied, and what are the key features of its design?

The Ziehm 8000 is supplied as a mobile C-arm system, featuring a compact and ergonomic design. This allows for easy positioning around the patient and flexibility in operating rooms or interventional suites, making it ideal for intraoperative use.

What regulatory pathways has the Ziehm 8000 followed, and which governing bodies have authorized its use?

The Ziehm 8000 has received FDA 510(k) clearance and complies with the Medical Devices Directive (MDD). It is classified as a Class II device under FDA regulations, indicating it has undergone substantial equivalence reviews by the Radiology (RA) Advisory Committee.

Are there multiple model variants of the Ziehm 8000, and how can I verify the specific variant I am considering?

Yes, multiple model variants of the Ziehm 8000 are authorized, each associated with distinct registration numbers (e.g., 3005706667, 3003768251, etc.). To verify the variant, check the registration number listed on the device or consult the manufacturer’s documentation, as these numbers correspond to specific configurations or features.

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: Home - Ziehm Imaging | EN, PDF Ziehm 8000 Proven C-arm technology - EBA AG, Ziehm 8000 8000 Technical Manual | Manualzz, Home - Ziehm Imaging | EN

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Ziehm Imaging GmbH

Sources (2)

  • FDA 510(k) K190497 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 18, 2026