# K122878: HD-Ivus Ultrasound Imaging System

- Pathway: 510(k) (Special)
- Applicant: Silicon Vally Medical Instruments, Inc.
- Decided: Jan 11, 2013 after 114 days
- Product code: OBJ (Catheter, Ultrasound, Intravascular)
- Device class: 2
- Regulation: 21 CFR 870.1200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K921750 (1992). 6 ancestors in all.
3 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.
- K112997: HD-Ivus Ultrasound Imaging System, Silicon Vally Medical Instruments, Inc. (2011) Summary page 5.

## Most influential descendants
- 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 HD-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/K122878
Methodology: https://510kreport.com/methodology