# K240284: Digital Radiography System (MobileApex 60E, MobileApex 60F, MobileApex 60G, MobileApex 60H)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Browiner Tech Co., Ltd.
- Decided: Mar 28, 2024 after 56 days
- Product code: IZL (System, X-Ray, Mobile)
- Device class: 2
- Regulation: 21 CFR 892.1720
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K896095 (1990). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181874: MX40 Mobile Digital X-ray System, Huestis Machine Corporation (2018) Summary page 5.

## Indications for use
Intended for use by a qualified/trained doctor or technician on adult subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.

Source page: https://510kreport.com/device/K240284
Methodology: https://510kreport.com/methodology