# K153429: SmartView 3D Option

- Pathway: 510(k) (Traditional)
- Applicant: Ge Hangwei Medical System Co., Ltd.
- Decided: Mar 9, 2016 after 105 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- 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 K940606 (1994). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973168: Smartview Options for Hispeed CT/I, GE Medical Systems (1997) Summary page 4.

## Indications for use
The SmartView 3D option is used as part of a head or whole body CT interventional procedure when the physician desires to obtain a visualization, 3D orientation, and localization of the needle in patients of all ages. SmartView 3D can automatically detect various sized needles during CT interventional procedures. SmartView 3D reconstructs and displays the traditional 2D images, and immediately thereafter additionally displays Multiple Planar Reconstruction images from a reconstruction in an orthogonal reference frame aligned with the needle’s orientation where the needle tip is at the origin. This additional information may aid in guidance and/or monitoring during interventional procedures.

Source page: https://510kreport.com/device/K153429
Methodology: https://510kreport.com/methodology