# K163429: B6

- Pathway: 510(k) (Traditional)
- Applicant: Beijing East Whale Imaging Technology Co., Ltd.
- Decided: Jan 4, 2017 after 28 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: 9 generations back to K021049 (2002). 11 ancestors in all.
No later device cites it as a predicate yet.
2 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160984: MultiScan G-Arm System, Beijing East Whale Imaging Technology Co., Ltd. (2016) Summary page 5.

## Indications for use
The B6 is a mobile digital X-ray 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 B6 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.

Source page: https://510kreport.com/device/K163429
Methodology: https://510kreport.com/methodology