# K173063: ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System

- Pathway: 510(k) (Special)
- Applicant: Acist Medical Systems, Inc.
- Decided: Oct 23, 2017 after 24 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: 5 generations back to K921750 (1992). 8 ancestors in all.
2 later devices descend from it; 1 cites it directly.
1 of 11 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122878: HD-Ivus Ultrasound Imaging System, Silicon Vally Medical Instruments, Inc. (2013) Summary page 4.
- K113008: Kodama Intravascular Ulrasound Catheter, Silicon Vally Medical Instruments, Inc. (2012) Summary page 4.

## Most influential descendants
- 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
The ACIST HDi System is intended to be used for the intravascular ultrasound imaging assessment of coronary artery disease. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures. The ACIST Kodama Intravascular Ultrasound Catheter is a medical device for use by or on the order of a physician and 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/K173063
Methodology: https://510kreport.com/methodology