# K101166: 4D-View 9.1 (4D View PC Software) Model: H48651SZ

- Pathway: 510(k) (Traditional)
- Applicant: GE Healthcare
- Decided: Oct 7, 2010 after 164 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: 6 generations back to K950279 (1995). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 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.
- K061682: GE Voluson E8 Ultrasound System, General Electric Co. (2006) Summary page 1.

## Indications for use
Image Display of GE Ultrasound 3D/4D data sets for diagnostic purposes including measurements on displayed image.

Source page: https://510kreport.com/device/K101166
Methodology: https://510kreport.com/methodology