# K162868: Exam Vue PACS

- Pathway: 510(k) (Traditional)
- Applicant: Jpi Healthcare Solutions, Inc.
- Decided: Mar 17, 2017 after 155 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K930527 (1993). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092081: Qxlink, Vieworks Co., Ltd. (2009) Summary page 4.
- K061035: Tigerview Professional, Televere Systems (2006) Summary page 4.

## Most influential descendants
- K213520: Axir-CX (2022), 0 descendants of its own

## Indications for use
ExamVue PACS is an image management system intended to be used by trained professionals, including physicians, radiologists, nurses and medical technicians. The software is a software package used with general purpose computing hardware to receive, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital image processing, measurement, communication and storage. This device is not indicated for use in mammography. ExamVue PACS supports receiving, sending, printing, storing and displaying studies received from the following modality types via DICOM: CR and DX.

Source page: https://510kreport.com/device/K162868
Methodology: https://510kreport.com/methodology