# K061310: Ziehm Vario 3D Digital Mobile Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Ziehm Imaging, Inc.
- Decided: Jul 7, 2006 after 58 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K003266 (2000). 4 ancestors in all.
29 later devices descend from it; 1 cites it directly.
1 of 34 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003266: Siremobil Iso-C 3D, Siemens Medical Solutions USA, Inc. (2000) Summary page 1.
- K032280: Siremobil Iso-C 3D, Siemens AG (2003) Summary page 1.

## Most influential descendants
- K073346: Ziehm Vision 2 (2008), 28 descendants of its own
- K083545: Ziehm Vision RFD (2009), 17 descendants of its own
- K132904: Ziehm Vision RFD (2013), 16 descendants of its own
- K142740: Ziehm Vision RFD 3D (2015), 10 descendants of its own
- K092438: Ziehm Solo (2009), 9 descendants of its own

## Indications for use
The ZIEHM VARIO and ZIEHM VARIO 3-D C-arms provide fluoroscopic and spot film imaging of the patient during diagnostic, Interventional and surgical procedures. It is intended to be used whenever the Clinician benefits from Iso-centric positioning and/or intraoperatively generated 3D imaging of high contrast objects (bones and joints), complex anatomical structures such as cervical, thoracic, and lumber regions of the spine and joint fractures of the upper and lower extremities. The design includes features intended for performing vascular, angiographic, cholangiography, endoscopic, urologic, orthopedic, neurologic, and critical care and emergency room procedures. At the discretion of a physician the device may be used for other imaging applications. Radiographic film examinations can be made with an accessory cassette device attached to the Image Intensifier.

Source page: https://510kreport.com/device/K061310
Methodology: https://510kreport.com/methodology