# K083728: Invision System

- Pathway: 510(k) (Traditional)
- Applicant: Inneroptic Technology, Inc.
- Decided: Aug 12, 2009 after 239 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K882383 (1988). 14 ancestors in all.
8 later devices descend from it; 2 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974432: Ultraguide 1000, Ultraguide, Ltd. (1998) Summary page 2.
- K060903: IG4 Image Guided System, Veran Medical Technologies, Inc. (2006) Summary page 2.
- K071063: Linasys, Pathfinder Therapeutics, Inc. (2007) Summary page 2.
- K001362: Karl Storz 3D Video System, Karl Storz Imaging, Inc. (2000) Summary page 2.

## Most influential descendants
- K121479: AIM (2012), 5 descendants of its own
- K141806: Clear Guide One (2014), 2 descendants of its own
- K132744: Acessa Guidance System (2014), 1 descendant of its own
- K101979: Explorer Liver (Passive Tracking) (2011), 1 descendant of its own
- K211529: NAVIRFA Scope (2022), 0 descendants of its own

## Indications for use
The InVision System is indicated for enhancing the ultrasonic image of an interventional needle or needle-like rigid device, such as a biopsy needle, an aspiration needle, or ablation needle, and for predicting its future path on a stereoscopic computer monitor screen which also shows the image of a B-scan (or similar display) of a medical ultrasound imaging system. The device is intended to be used in procedures where ultrasound is currently used for visualizing such procedures.

Source page: https://510kreport.com/device/K083728
Methodology: https://510kreport.com/methodology