# K242731: MasteRad MiniX Mobile Digital Imaging System (Mini-X)

- Pathway: 510(k) (Traditional)
- Applicant: Medicatech USA, Inc.
- Decided: May 16, 2025 after 248 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: 7 generations back to K973598 (1997). 11 ancestors in all.
No later device cites it as a predicate yet.
1 of 12 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212523: VFSS Pro Mobile Digital Imaging System, Imagexray, LLC (2021) Summary page 5.
- K210469: Insight Agile DRF, Imaging Engineering, LLC (2021) Summary page 5.
- K212557: Virtual C DRF-NEO Digital Imaging System, Portavision Medical, LLC (2021) Summary page 5.

## Indications for use
Mini-X is intended for use by qualified/trained medical professionals who fully understand the safety information, emergency procedures, and the device's capabilities and function. The device provides fluoroscopic imaging and is used for guidance and visualization during diagnostic radiography and surgical procedures of the extremities. The device will be used in healthcare facilities inside and outside the hospital, using various methods for the extremities on all patients except neonates (birth to one month) within the limits of the device. Applications can be performed with the patient sitting, standing, or lying in a prone or supine position. The system is not intended for mammography applications. (Rx Only)

Source page: https://510kreport.com/device/K242731
Methodology: https://510kreport.com/methodology