Identifiers
- 510(k) Number
- K234109 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 Solo FD is an Interventional Fluoroscopic X‑Ray System classified as a Class II device. It provides mobile C‑arm fluoroscopic imaging for a range of radiology procedures, delivering real‑time X‑ray visualization to guide interventions.
The system is supplied as a compact, mobile C‑arm equipped with a flat‑panel detector available in 21 cm × 21 cm or 31 cm × 31 cm sizes, allowing use in space‑constrained operating rooms and treatment suites. It received a special FDA 510(k) clearance as substantially equivalent to a predicate device and is identified by product code OWB and K‑number K234109.
Frequently asked questions
What is the Ziehm Solo FD used for?
The Ziehm Solo FD is an Interventional Fluoroscopic X-Ray System designed to provide mobile C-arm fluoroscopic imaging for a range of radiology procedures, delivering real-time X-ray visualization to guide interventions in space-constrained operating rooms and treatment suites.
What sizes are available for the flat-panel detector?
The Ziehm Solo FD is equipped with a flat-panel detector available in two sizes: 21cm×21cm or 31cm×31cm, allowing flexibility depending on the specific procedural requirements and space constraints in the operating room.
What is the regulatory status of the Ziehm Solo FD?
The Ziehm Solo FD has received FDA 510(k) clearance as substantially equivalent to a predicate device, with product code OWB and K-number K234109. It is classified as a Class II device for interventional fluoroscopic X-ray imaging.
How is the Ziehm Solo FD supplied?
The system is supplied as a compact, mobile C-arm unit equipped with a flat-panel detector. It is designed to be mobile, allowing it to be easily positioned in various locations within operating rooms and treatment suites as needed for different 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 Solo FD - the compact mobile C-arm - Ziehm Imaging | EN, Ziehm Solo FD - Ziehm Imaging | EN, SOLO FD - Mobile C-arm by Ziehm Imaging | MedicalExpo
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K234109 | Class II | Active |
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Manufacturer
- Manufacturer
- Ziehm Imaging GmbH
Sources (1)
- FDA 510(k) K234109 24 fields · synced Sep 24, 2026