# K092639: Innova Vision, Model S18751VN, Innova Trackvision, Model S18751VT, Innova Epvision, Model S18751EP

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems SCS
- Decided: Dec 2, 2009 after 97 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: 4 generations back to K913770 (1991). 12 ancestors in all.
65 later devices descend from it; 7 cite it directly.
0 of 78 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K852353: DG 200/300 Digital Angiographic System, Thomson-Cgr Medical Corp. (1985) Summary page 1.
- K052995: Advantage Workstation 4.3., GE Healthcare (2005) Summary page 1.
- K041521: Volume Viewer Plus, General Electric Medical Systems (2004) Summary page 1.
- (no number) EP-Navigator: named in the summary without a submission number

## Cited in the summary but kept off the family tree
- K090041: Innova 4100, 3100, 2100 with StentViz. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree

## Most influential descendants
- K101311: EP Navigator R3 (2010), 41 descendants of its own
- K111245: Heartnavigator Release 1 (2011), 39 descendants of its own
- K121781: Echonavigator Release 1 (2012), 32 descendants of its own
- K172607: Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System, Affiniti 30 Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System (2017), 28 descendants of its own
- K181485: EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound System (2018), 27 descendants of its own

## Indications for use
Innova Vision Applications software is 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.

Source page: https://510kreport.com/device/K092639
Methodology: https://510kreport.com/methodology