# K120034: Radiographic X-Ray System

- Pathway: 510(k) (Traditional)
- Applicant: Orich Medical Equipment (Tianjin Co., Ltd.
- Decided: Apr 17, 2012 after 104 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: 2 generations back to K001201 (2000). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052541: Model HF-50R Computer Controlled X-Ray System, Avant Medical Systems (2005) Summary page 1.

## Most influential descendants
- K152813: FS-500DDR Medical Radiographic X-Ray System (2016), 0 descendants of its own

## Indications for use
DF-21 I1H Radiographic X-Ray system is designed to be. used by a qualified/trained doctor or technician on adult and pediatric patients for taking diagnostic images of the skull, spinal colum, chest, abdomen, extremities and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.

Source page: https://510kreport.com/device/K120034
Methodology: https://510kreport.com/methodology