# K253296: Digital C-ARM with 3D

- Pathway: 510(k) (Traditional)
- Applicant: Allengers Medical Systems Limited
- Decided: Jun 5, 2026 after 249 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: 13 generations back to K801623 (1980). 102 ancestors in all.
No later device cites it as a predicate yet.
3 of 103 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200218: Digiscan FDX, Allengers Medical Systems Limited (2020) Summary page 5.
- K210054: Cios Spin, Siemens Medical Systems USA, Inc. (2021) Summary page 5.
- K243303: Ziehm Vision RFD 3D, Ziehm Imaging GmbH (2025) Summary page 6.

## Indications for use
Digiscan V30 3D is X-Ray based fluoroscopy equipment. It is intended for use in visualizing complex anatomical structures and procedures such as 3D Reconstruction, endoscopy Studies (ERCP), urology, Gastro, orthopedic, neurology, Fertility studies (HSG), cholangiography, vascular angiography with and without subtraction, critical care and emergency room procedures. This equipment produces real time images of anatomy using x-rays. Exclusion: Device is not meant for Mammography. Contraindications of device: Exposure of X-ray should be avoided during pregnancy.

Source page: https://510kreport.com/device/K253296
Methodology: https://510kreport.com/methodology