# K230918: MasterX 800 Series

- Pathway: 510(k) (Traditional)
- Applicant: Medicatech USA
- Decided: Sep 1, 2023 after 151 days
- Product code: MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager))
- Device class: 2
- Regulation: 21 CFR 892.1680
- 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 K896095 (1990). 28 ancestors in all.
No later device cites it as a predicate yet.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130377: Krystalrad New Seriesdigital Radiographic Portable Retrofit System, Medicatech USA (2013) Summary page 4.

## Indications for use
The MasterX 800 Series is intended for use by a qualified/trained doctor or technologist. As part of a radiographic system, the MasterX 800 Series is intended to acquire digital radiographic images on adult and pediatric patients. It is suitable for all routine radiography exams, including specialist areas like intensive care or trauma work, excluding fluoroscopy, angiography and mammography.

Source page: https://510kreport.com/device/K230918
Methodology: https://510kreport.com/methodology