# K170946: Skan-C Mobile C-Arm X-Ray System - 230V Variant, Skan-C Mobile C-Arm X-Ray System - 110V Variant

- Pathway: 510(k) (Traditional)
- Applicant: Skanray Technologies Private Limited
- Decided: Nov 24, 2017 after 239 days
- Product code: OXO (Image-Intensified Fluoroscopic X-Ray System, Mobile)
- 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: 1 generation back to K043076 (2004). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043076: GE Oec Fluorostar, Ge Oec Medical Systems, Inc. (2004) Summary page 4.

## Most influential descendants
- K251893: Skan C Pulsar (2025), 0 descendants of its own

## Indications for use
The Skan-C, a Mobile Surgical C-Arm X-Ray System, is intended to provide Fluoroscopic and Radiographic images of the patient during Diagnostic, Surgical and Interventional procedures. Examples of Clinical Applications may include Orthopaedic, GI Procedure like Endoscopy and Cholenography, Neurology, Urology Procedures, Vascular, Critical Care and Emergency Room Procedures. Skan-C is not recommended for Cardiac Applications. Skan-C Surgical C-Arm is indicated for visualization in real time and/or recording of surgical region of interest and anatomy, using X-ray imaging technique.

Source page: https://510kreport.com/device/K170946
Methodology: https://510kreport.com/methodology