# K151280: MultiScan G-Arm System

- Pathway: 510(k) (Special)
- Applicant: Beijing East Whale Imaging Technology Co., Ltd.
- Decided: Sep 30, 2015 after 139 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: 7 generations back to K021049 (2002). 9 ancestors in all.
3 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)
- K131423: G-Arm Multiscan System, Beijing East Whale Imaging Technology Co., Ltd. (2013) Summary page 5.
- K141672: Digiarc 100AU+, Beijing East Whale Imaging Technology Co., Ltd. (2014) Summary page 5.

## Most influential descendants
- 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 100AU/ DigiArc 100AU+ 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 DigiArc 100AU/ DigiArc 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/K151280
Methodology: https://510kreport.com/methodology