# K142930: Exam Vue DR

- Pathway: 510(k) (Traditional)
- Applicant: Jpi Healthcare Co, Ltd.
- Decided: Apr 17, 2015 after 190 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: 8 generations back to K896095 (1990). 10 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110033: Feel-DRCS, Imfou Co., Ltd. (2011) Summary page 4.

## Most influential descendants
- K213057: ExamVue Duo (2022), 0 descendants of its own

## Indications for use
ExamVue DR is a software for the acquisition, processing, storage and viewing of two-dimensional digital radiology images. ExamVue DR is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects. ExamVue DR is indicated for use in general radiology, specialist radiology including podiatry, orthopedic, and other specialties, and in mobile x-ray systems. ExamVue DR is not indicated for use in mammography.

Source page: https://510kreport.com/device/K142930
Methodology: https://510kreport.com/methodology