# K131423: G-Arm Multiscan System

- Pathway: 510(k) (Traditional)
- Applicant: Beijing East Whale Imaging Technology Co., Ltd.
- Decided: Nov 7, 2013 after 175 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: 5 generations back to K021049 (2002). 7 ancestors in all.
5 later devices descend from it; 2 cite it directly.
2 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120613: Oec 9900 Elite, Ge Healthcare Surgery GE Oec Medical Systems, Inc. (2012) Summary page 2.
- K911739: Swemac Reison Biplanar 300, Seemac Reison AB Co. (1991) Summary page 2.

## Most influential descendants
- K141672: Digiarc 100AU+ (2014), 4 descendants of its own
- K151280: MultiScan G-Arm System (2015), 3 descendants of its own
- K160984: MultiScan G-Arm System (2016), 1 descendant of its own
- K251004: Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M) (2025), 0 descendants of its own
- K163429: B6 (2017), 0 descendants of its own

## Indications for use
The DigiArc IOOAU is a mobile digital X-ray G-Arm diagnostic system, which Is Intended to generate X-ray fluoroscopic image of a patient. The application includes: real-time positioning and monitoring operations in trauma surgery, orthopedics, spine surgery, and chest surgery, it is not intended to be used in interventional procedures. The DigiAro 100AU permits a qualified doctor or technologist to take a range of diagnostic exposures of spinal column, chest, abdomen, extremities, and other body parts on the patients at the age of at least eighteen.

Source page: https://510kreport.com/device/K131423
Methodology: https://510kreport.com/methodology