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Ziehm Vision FD

FDA 510(k)

Class II (US FDA 510(k))

510(k) K193230

by Ziehm Imaging GmbH

Identifiers

510(k) Number
K193230 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 Vision FD is an interventional fluoroscopic X-ray system, a mobile C-arm device that uses CMOS flat-panel technology for excellent image quality. It is available with a 21 cm x 21 cm or 31 cm x 31 cm flat-panel and features liquid cooling for suitability in long-lasting procedures.

The device is supplied by Ziehm Imaging GmbH and has received FDA 510(k) clearance with the K number K193230. It is regulated under product code OWB and regulation number 892.1650, with a device class of 2. The device is intended for use in radiology applications.

Frequently asked questions

What is the Ziehm Vision FD used for?

The Ziehm Vision FD is an interventional fluoroscopic X-ray system designed for radiology applications. It's a mobile C-arm device that provides high-quality imaging during medical procedures, particularly suitable for long-lasting operations due to its liquid cooling system.

What are the available configurations for the Ziehm Vision FD?

The Ziehm Vision FD is available with two flat-panel size options: 21 cm x 21 cm or 31 cm x 31 cm. Both configurations utilize CMOS flat-panel technology to ensure excellent image quality during interventional procedures.

What is the regulatory status of the Ziehm Vision FD?

The Ziehm Vision FD has received FDA 510(k) clearance with K number K193230. It is regulated under product code OWB and regulation number 892.1650, with a device class of 2. The device is intended for use in radiology applications.

How is the Ziehm Vision FD supplied?

The Ziehm Vision FD is supplied by Ziehm Imaging GmbH, located in Nuremberg, Germany. The device is manufactured with liquid cooling technology specifically designed to maintain performance during lengthy medical procedures.

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: Ziehm Vision FD - the established mobile C-arm - Ziehm Imaging | EN, Ziehm Vision FD - Ziehm Imaging | EN, PDF Ziehm Vision / Ziehm Vision FD The new standard in mobile

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Ziehm Imaging GmbH

Sources (1)

  • FDA 510(k) K193230 24 fields · synced Sep 24, 2026