# K190601: MasteRad MX30

- Pathway: 510(k) (Traditional)
- Applicant: Medicatech USA
- Decided: Apr 25, 2019 after 48 days
- Product code: KPR (System, X-Ray, Stationary)
- 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: 8 generations back to K981556 (1998). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143257: KrystalRad 11000 and KrystalRad 3000 Digital Stationary Radiographic System, Medicatech USA (2015) Summary page 4.

## Indications for use
The MasteRad MX30 is intended for use by a qualified/trained doctor or technician on both adult and pediatric 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/K190601
Methodology: https://510kreport.com/methodology