# K143257: KrystalRad 11000 and KrystalRad 3000 Digital Stationary Radiographic System

- Pathway: 510(k) (Traditional)
- Applicant: Medicatech USA
- Decided: Feb 6, 2015 after 85 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: 7 generations back to K981556 (1998). 11 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133782: Nova FA DR System, Sedecal., Sa. (2014) Summary page 4.

## Most influential descendants
- K190601: MasteRad MX30 (2019), 0 descendants of its own
- K151219: Models 2200DR and 1600DR Digital Stationary Radiographic Systems (2015), 0 descendants of its own

## Indications for use
The KrystalRad 1100 and KrystalRad 3000 Digital Stationary Radiographic Systems are 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/K143257
Methodology: https://510kreport.com/methodology