# K251893: Skan C Pulsar

- Pathway: 510(k) (Traditional)
- Applicant: Skanray Technologies Limited
- Decided: Dec 16, 2025 after 179 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: 6 generations back to K042646 (2004). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230871: Extron 5; Extron 7, DRTECH Corporation (2023) Summary page 6.
- K170946: Skan-C Mobile C-Arm X-Ray System - 230V Variant, Skan-C Mobile C-Arm X-Ray System - 110V Variant, Skanray Technologies Private Limited (2017) Summary page 6.

## Indications for use
The SKAN C Pulsar, a Mobile Surgical C-Arm X-Ray System, is intended to provide Fluoroscopic images of patients during Diagnostic, Surgical and Interventional procedures. SKAN C Pulsar is to be used by adequately trained, qualified and authorized healthcare professionals. Clinical Applications may include Orthopedic, GI Procedure, Neurology, Urology Procedures, Vascular in Critical Care and Emergency Room Procedures. SKAN C Pulsar is not recommended for Cardiac Applications. SKAN C Pulsar 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/K251893
Methodology: https://510kreport.com/methodology