# K173456: ViewPoint 6

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems Ultrasound and Primary
- Decided: Jan 5, 2018 after 59 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K162743: ViewPoint 6, GE Medical Systems Ultrasound and Primary Care Diagnostics (2016). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K192917: ViewPoint 6 (2020), 2 descendants of its own
- K203677: ViewPoint 6 (2021), 1 descendant of its own
- K241300: ViewPoint 6 (2024), 0 descendants of its own

## Recalls of this device
- Aug 8, 2024 · Class II · Z-3146-2024: The National Institute of Standards and Technology (NIST) has identified in the National Vulnerability Database (NVD) that NexGen Healthcare Mirth Connect, prior to version 4.4.1, has a potential vuln

## Indications for use
ViewPoint 6 is intended to be used in medical practices and in clinical departments and serves the purposes of diagnostic interpretation of images, electronic documentation of examinations in the form of text and images, and generation of medical reports primarily for diagnostic ultrasound. ViewPoint 6 provides the user the ability to include images, drawings, and charts into medical reports. ViewPoint 6 is designed to accept, transfer, display, calculate, store, and process medical images and data, and enables the user to measure and annotate the images. The medical images, which ViewPoint 6 displays to the user, can be used for diagnostic purposes. ViewPoint 6 is intended for professional use only. ViewPoint 6 is not intended to be used as an automated diagnosis system. ViewPoint 6 is not intended to operate medical devices in surgery related procedures.

Source page: https://510kreport.com/device/K173456
Methodology: https://510kreport.com/methodology