# K152352: Stereo 3D option for Vision Applications

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems SCS
- Decided: Jan 20, 2016 after 153 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 K890348 (1989). 27 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092639: Innova Vision, Model S18751VN, Innova Trackvision, Model S18751VT, Innova Epvision, Model S18751EP, GE Medical Systems SCS (2009) Summary page 5.
- K052412: Innova 2100-IQ, Innova 3100, Innova 3100-IQ, Innova 4100, and Innova 4100-IQ, GE Healthcare (2005) Summary page 5.

## Most influential descendants
- K223152: Vision 2, EVARVision, TrackVision 2, HeartVision 2 (2022), 0 descendants of its own

## Indications for use
Vision 2, TrackVision 2 and HeartVision 2 software applications are intended to enable users to load 3D datasets and overlay and register in real time these 3D datasets with radioscopic or radiographic images of the same anatomy in order to support catheter/device guidance during interventional procedures. The Stereo 3D option enables physicians to visualize and localize needles, points, and segments on a 3D model/space using a stereotactic reconstruction of radioscopic or radiographic images at a significantly lower dose than use of a full cone beam CT acquisition. This information is intended to assist the physician during interventional procedures.

Source page: https://510kreport.com/device/K152352
Methodology: https://510kreport.com/methodology