# K130069: Innova Epvision 2.0, Innova Epvision 2.0

- Pathway: 510(k) (Traditional)
- Applicant: GE Healthcare
- Decided: Apr 5, 2013 after 84 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: 5 generations back to K913770 (1991). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 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 1.

## Indications for use
Innova EP'Vision 2.0 software application is intended to enable users to load, overlay and register in real time 3D datasets with radioscopic or radiographic images of the same anatomy. Electrophysiology signal information is imported and used to color-code these 3D datasets in order to support catheter/device guidance during cardiac electrophysiology interventional procedures.

Source page: https://510kreport.com/device/K130069
Methodology: https://510kreport.com/methodology