# K152813: FS-500DDR Medical Radiographic X-Ray System

- Pathway: 510(k) (Traditional)
- Applicant: Orich Medical Equipment (Tianjin) Co., Ltd.
- Decided: Dec 2, 2016 after 431 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: 4 generations back to K862120 (1986). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012389: Revolution XR/D Digital Radiographic Imaging System, Ge Medical Systems, Inc. (2001) Summary page 4.
- K120034: Radiographic X-Ray System, Orich Medical Equipment (Tianjin Co., Ltd. (2012) Summary page 4.

## Indications for use
FS-500DDR Medical 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 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.

Source page: https://510kreport.com/device/K152813
Methodology: https://510kreport.com/methodology