# K130377: Krystalrad New Seriesdigital Radiographic Portable Retrofit System

- Pathway: 510(k) (Special)
- Applicant: Medicatech USA
- Decided: May 17, 2013 after 92 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: 8 generations back to K896095 (1990). 27 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112132: Krystalrad 660 Digital Radiographic Portable Retrofit System, Medicatech USA (2011) Summary page 1.

## Most influential descendants
- K230918: MasterX 800 Series (2023), 0 descendants of its own

## Indications for use
Intended for use by a qualified/trained doctor or technologist. As part of a radiographic system, the KrystalRad "New Series" is intended to acquire digital radiographic images. 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/K130377
Methodology: https://510kreport.com/methodology