# K200218: Digiscan FDX

- Pathway: 510(k) (Traditional)
- Applicant: Allengers Medical Systems Limited
- Decided: Jul 13, 2020 after 167 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: 9 generations back to K021049 (2002). 40 ancestors in all.
1 later device descends from it; 1 cites it directly.
3 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132904: Ziehm Vision RFD, Ziehm Imaging GmbH (2013) Summary page 5.
- K172550: OEC Elite, Ge Oec Medical Systems, Inc. (2017) Summary page 5.
- K153244: Cios Fusion, Siemens Medical Solutions USA, Inc. (2016) Summary page 6.

## Most influential descendants
- K253296: Digital C-ARM with 3D (2026), 0 descendants of its own

## Indications for use
The Digiscan FDX Family, a Mobile C-Arm X-Ray System, is intended to provide Fluoroscopic images of the patient during diagnostic, surgical procedures. Clinical applications may include (but not limited to) orthopedic, Fertility studies (HSG), GI procedures like endoscopy , neurology, urology, critical care and emergency room procedures. Digiscan FDX C-Arm is indicated for visualization in real time and/or recording of surgical region of interest and anatomy, using X-Ray imaging technique. Exclusion: Digiscan FDX Family is not recommended for Mammography. Contraindications: Exposure of X-Ray should be avoided during pregnancy.

Source page: https://510kreport.com/device/K200218
Methodology: https://510kreport.com/methodology