# K103458: Viewpoint 6

- Pathway: 510(k) (Traditional)
- Applicant: GE Healthcare
- Decided: Mar 4, 2011 after 101 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K950279 (1995). 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)
- K050943: GE Viewpoint, General Electric Co. (2005) Summary page 1.

## Most influential descendants
- K162743: ViewPoint 6 (2016), 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
- Aug 7, 2013 · Class II · Z-2098-2013: GE has recently become aware of a potential safety issue due to the incorrect calculation of the pulsatility index value (PIV) for venous flow measurements associated with obstetric reporting of the G

## Indications for use
ViewPoint 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 provides the user the ability to include images, drawings, and charts into medical reports. ViewPoint 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 displays to the user, can be used for diagnostic purposes. ViewPoint is intended for professional use only. ViewPoint is not intended to be used as an automated diagnosis system. Viewpoint is not intended to operate medical devices in surgery related procedures.

Source page: https://510kreport.com/device/K103458
Methodology: https://510kreport.com/methodology