# K051920: Volcano S5 Imaging System, Model 804200-001

- Pathway: 510(k) (Special)
- Applicant: Volcano Corporation
- Decided: Aug 19, 2005 after 35 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K944004 (1995). 4 ancestors in all.
614 later devices descend from it; 2 cite it directly.
1 of 619 devices in its family (counting itself) has 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.
- K031148: IN-Vision Imaging System, Jomed, Inc. (2003) Summary page 1.

## Most influential descendants
- 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
- K113690: GE Logiq I, Logiq E and Vivid E (2011), 469 descendants of its own

## Recalls of this device
- Apr 2, 2007 · Not classified · Z-1190-2007: During emissions testing, it was discovered that the product exceeds emissions limits for electromagnetic compatibility.

## Indications for use
The Volcano s5 Imaging 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 from peripheral and coronary vasculature; flow information can be an adjunct to other methods of estimating blood flow and blood perfusion.

Source page: https://510kreport.com/device/K051920
Methodology: https://510kreport.com/methodology