# K050943: GE Viewpoint

- Pathway: 510(k) (Traditional)
- Applicant: General Electric Co.
- Decided: May 23, 2005 after 39 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
Longest line of descent: 5 generations back to K950279 (1995). 9 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041029: Kinetdx, Siemens Medi Cal Solutions, Inc. (2004) Summary page 1.

## Most influential descendants
- K103458: Viewpoint 6 (2011), 1 descendant of its own
- K162743: ViewPoint 6 (2016), 0 descendants of its own
- K101166: 4D-View 9.1 (4D View PC Software) Model: H48651SZ (2010), 0 descendants of its own

## Recalls of this device
- Aug 8, 2024 · Class II · Z-3145-2024: 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
The GE ViewPoint is intended to accept, transfer, display, store and process medical images and data, including the ability to measure, calculate, annotate and prepare and print patient examination reports primarily for diagnostic ultrasound.

Source page: https://510kreport.com/device/K050943
Methodology: https://510kreport.com/methodology