# K223152: Vision 2, EVARVision, TrackVision 2, HeartVision 2

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems SCS
- Decided: Nov 22, 2022 after 47 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: 7 generations back to K890348 (1989). 28 ancestors in all.
No later device cites it as a predicate yet.
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 4.
- K152352: Stereo 3D option for Vision Applications, GE Medical Systems SCS (2016) Summary page 4.

## Indications for use
Vision 2, TrackVision 2, EVARVision 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. Structures of interest and estimated dimensions can be overlaid on the radioscopic or radiographic images. Image processing can be applied to enhance the display of such images. This information is intended to assist the physician 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/K223152
Methodology: https://510kreport.com/methodology