# K101779: Clearvision DR 2000 Digital Radiography X-Ray System

- Pathway: 510(k) (Traditional)
- Applicant: Jpi Healthcare Co, Ltd.
- Decided: May 16, 2011 after 325 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: 5 generations back to K862120 (1986). 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)
- K083640: Digital X-Ray Imaging System, Model: CXD-DR80D, Choong Wae Medical Corp. (2009) Summary page 1.
- K073056: Digital Radiography System, Model: QXR-9, Vieworks Co., Ltd. (2007) Summary page 2.
- K080553: Digital Radiography System, Model QXR-16, Vieworks Co., Ltd. (2008) Summary page 1.

## Indications for use
The Clear Vision DR 2000 product 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. The Clear Vision DR 2000 system is intended to be used in medical clinics and hospitals for emergency, orthopedic, chiropractic, and other medical purposes. This device is not indicated for use in mammography.

Source page: https://510kreport.com/device/K101779
Methodology: https://510kreport.com/methodology