# K073346: Ziehm Vision 2

- Pathway: 510(k) (Traditional)
- Applicant: Ziehm Imaging, Inc.
- Decided: Mar 21, 2008 after 113 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K003266 (2000). 7 ancestors in all.
28 later devices descend from it; 4 cite it directly.
1 of 36 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011292: Ziehm Vision, Ziehm International, Inc. (2001) Summary page 2.
- K061534: Ziehm Vision FD Digital Mobile Imaging System, Ziehm Imaging, Inc. (2006) Summary page 2.
- K061310: Ziehm Vario 3D Digital Mobile Imaging System, Ziehm Imaging, Inc. (2006) Summary page 2.

## Most influential descendants
- 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
- K161976: Ziehm Solo FD (2016), 8 descendants of its own

## Recalls of this device
- Aug 8, 2024 · Class II · Z-0575-2025: Ziehm Imaging, Inc., distributor, have been informed by manufacturer, Ziehm Imaging GmbH that installed devices may not fully meet the requirements of IEC 60601-2-54 and or 21 CFR 1020.32(c) with resp
- Apr 15, 2016 · Class II · Z-2644-2016: Malfunction of the radiation-warning timer and the 3D-specific interval warning. No 5-minute timer dialogs or beeper will occur until the unit is rebooted.
- Nov 21, 2013 · Class II · Z-0564-2014: Engineering change in 2006 resulted in a minor non-conformity of their devices. Specifically the emergency switch was changed from a standard component to just an option on the devices.
- Nov 21, 2013 · Class II · Z-0565-2014: Engineering change in 2006 resulted in a minor non-conformity of their devices. Specifically the emergency switch was changed from a standard component to just an option on the devices.
- Apr 29, 2011 · Not classified · Z-1430-2012: On 04/29/2011, Ziehm Imaging, Inc., Orlando, FL recalled the double foot switch, type KF 2 1S/1S-MED-AP, a component used with Ziehm Imaging GmbH Mobile C-arm due to the potential of unintentional con

## Indications for use
The ZIEHM VISION’ product Family is intended to provide pulsed and continuous fluoroscopic imaging of patients during diagnostic, interventional and surgical procedures. It is intended for use in visualizing complex anatomical structures and procedures such as, vascular, cardiac, angiographic, cholangiography, endoscopic, urologic, orthopedic, neurological, critical care, and emergency room procedures. Radiographic film examinations can be made with an accessory cassette device when attached to the Image Intensifier. At the discretion of a physician the device may be used for other imaging applications. ZIEHM VISION with option VARIO is intended to provide pulsed and continuous fluoroscopic imaging of patients during diagnostic, interventional and surgical procedures. It is intended for use in visualizing complex anatomical structures and procedures such as, vascular, cardiac, angiographic, cholangiography, endoscopic, urologic, orthopedic, neurological, critical care, and emergency room procedures. and whenever the clinician benefits from variable Iso-centric positioning. Radiographic film examinations can be made with an accessory cassette device when attached to the Image Intensifier. At the discretion of a physician the device may be used for other imaging applications. ZIEHM VISION® with option FD is intended to provide pulsed and continuous fluoroscopic imaging of patients during diagnostic, interventional and surgical procedures. It is intended for use in visualizing complex anatomical structures and procedures such as, vascular, cardiac, angiographic, cholangiography, endoscopic, urologic, orthopedic, neurological, critical care, and emergency room procedures and where higher accuracy in image geometry is required in and around high magnetic fields. At the discretion of a physician the device may be used for other imaging applications. ZIEHM VISION® with option 3D is intended to provide pulsed and continuous fluoroscopic imaging of patients during diagnostic, interventional and surgical procedures. It is intended for use in visualizing complex anatomical structures and procedures such as, vascular, cardiac, angiographic, cholangiography, endoscopic, urologic, orthopedic, neurological, critical care, and emergency room procedures and Whenever the clinician benefits from variable 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, and where digital image and c-arm positioning data is required for computer aided surgery procedures. Radiographic film examinations can be made with an accessory cassette device when attached to the Image Intensifier. At the discretion of a physician the device may be used for other imaging applications.

Source page: https://510kreport.com/device/K073346
Methodology: https://510kreport.com/methodology