# K051064: Ziehm Quantum

- Pathway: 510(k) (Traditional)
- Applicant: Ziehm Imaging, Inc.
- Decided: May 26, 2005 after 30 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K190497: Ziehm 8000 (2019), 0 descendants of its own

## Indications for use
The ZIEHM QUANTUM series Mobile C-Arm is intended for use in both Radiographic and Fluoroscopic exams, including a wide variety of surgical intervention or guidance procedures requiring X-ray imaging - both inside and outside the operating room. These include Cerebral, Thoracic, Vascular surgery; Abdominal, Orthopaedic, Peripheral, special Vascular-Flow Procedures, Dilatation, Em6lization, Stent Placement, Urological Procedures as well as Neuro-Vascular, and other related fluoroscopic examinations requiring interventional procedures. The ZIEHM QUANTUM Mobile C-arms are-also suitable as a back up for fixed-based X-ray Vascular and Intervention Procedures. Radiographic film examinations can be made with an accessory cassette device attached to the Image Intensifier.

Source page: https://510kreport.com/device/K051064
Methodology: https://510kreport.com/methodology