# K213057: ExamVue Duo

- Pathway: 510(k) (Traditional)
- Applicant: Jpi Healthcare Co, Ltd.
- Decided: Feb 18, 2022 after 149 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: 9 generations back to K896095 (1990). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142930: Exam Vue DR, Jpi Healthcare Co, Ltd. (2015) Summary page 4.

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

Source page: https://510kreport.com/device/K213057
Methodology: https://510kreport.com/methodology