# K031148: IN-Vision Imaging System

- Pathway: 510(k) (Special)
- Applicant: Jomed, Inc.
- Decided: May 28, 2003 after 48 days
- Product code: DXK (Echocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2330
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K944004 (1995). 3 ancestors in all.
648 later devices descend from it; 6 cite it directly.
6 of 652 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K944004: Visions 2.9F Ultrasonic Imaging Catheter (Model 84300), Endosonics Corp. (1995) Summary page 1.
- K963290: Colorflo Option for the Oracle Invision Intravascular Ultrasonic Imaging System, Endosonics Corp. (1997) Summary page 1.
- K965223: Resolve Option for the Oracle in Vision Intravascular Ultrasonic Imaging System, Endosonics Corp. (1998) Summary page 1.

## Most influential descendants
- K051920: Volcano S5 Imaging System, Model 804200-001 (2005), 614 descendants of its own
- K061215: Volcano S51 Family of Imaging Systems (2006), 613 descendants of its own
- K083095: Sonixtouch Ultrasound System (2008), 582 descendants of its own
- K092271: GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4 (2009), 569 descendants of its own
- K110943: Logiq E9 (2011), 472 descendants of its own

## Indications for use
In-VisionTMImaging System is used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature. It is also indicated as an adjunct to conventional angiographic procedures to provide an image of vessel lumen and wall structures. ChromaFlo is indicated for qualitative blood flow information frop peripheral and coronary vaculature; flow- information can be an adjunct to other methods of estimating blood flow and blood perfusion.

Source page: https://510kreport.com/device/K031148
Methodology: https://510kreport.com/methodology