# K032761: KMC-950 C-Arm Mobile System

- Pathway: 510(k) (Traditional)
- Applicant: United Radiology Systems, Inc.
- Decided: May 14, 2004 after 252 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
Longest line of descent: 2 generations back to K973598 (1997). 4 ancestors in all.
14 later devices descend from it; 5 cite it directly.
1 of 19 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021049: Oec 9800 Plus Digital Mobile Imaging System, Ge Oec Medical Systems (2002) Summary page 2.
- K973598: Siremobil CO2, Siemens Medical Solutions USA, Inc. (1997) Summary page 2.
- K993896: Mca-601, C-Arm Mobile, Medison Radiology Systems, Inc. (2000) Summary page 2.
- K022114: Imperium, Elmstech, Inc. (2002) Summary page 2.

## Most influential descendants
- K160279: ANYVIEW-500R Fluoroscopic Mobile X-Ray System (2016), 9 descendants of its own
- K191503: MobileRay Pulse SE Digital Imaging System (2019), 7 descendants of its own
- K211191: Virtual C DRF Digital Imaging System (2021), 5 descendants of its own
- K241567: MC2 Portable X-ray System (2024), 1 descendant of its own
- K212523: VFSS Pro Mobile Digital Imaging System (2021), 1 descendant of its own

## Indications for use
The KMC-950 is intended to provided fluoroscopic and radiographic imaging of the patient during diagnostic, surgical and interventional procedures. Clinical applications may include but are not limited to digital subtraction angiography, orthopedic, neurological, abdominal, vascular, cardiac, critical care and emergency room procedures. The system may be used for other RF imaging application at physician's discretion.

Source page: https://510kreport.com/device/K032761
Methodology: https://510kreport.com/methodology