# K112997: HD-Ivus Ultrasound Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Silicon Vally Medical Instruments, Inc.
- Decided: Dec 17, 2011 after 71 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- 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 K921750 (1992). 5 ancestors in all.
4 later devices descend from it; 1 cites it directly.
1 of 10 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051679: Ilab Ultrasound Imaging System, Boston Scientific Corp (2005) Summary page 1.

## Most influential descendants
- K122878: HD-Ivus Ultrasound Imaging System (2013), 3 descendants of its own
- K173063: ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System (2017), 2 descendants of its own
- K191175: ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System (2019), 1 descendant of its own
- K193183: ACIST HDi System, ACIST Kodama Intravascular Ultrasound Catheter (2020), 0 descendants of its own

## Indications for use
Silicon Valley Medical Instrument's HO-IVUS Ultrasound Imaging System (Console) is intended for ultrasound examination of coronary intravascular pathology only. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures.

Source page: https://510kreport.com/device/K112997
Methodology: https://510kreport.com/methodology