# K061215: Volcano S51 Family of Imaging Systems

- Pathway: 510(k) (Special)
- Applicant: Volcano Corporation
- Decided: Aug 10, 2006 after 100 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: 3 generations back to K944004 (1995). 5 ancestors in all.
613 later devices descend from it; 4 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.
- K051920: Volcano S5 Imaging System, Model 804200-001, Volcano Corporation (2005) Summary page 1.

## Most influential descendants
- 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
- K111582: Logiq S8 (2011), 367 descendants of its own

## Indications for use
The Volcano s5i Family of Imaging Systems 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/K061215
Methodology: https://510kreport.com/methodology