# K974457: Scout 3.2/45 MHZ Coronary Imaging Catheter, Scout 3.2/45 MHZ Coronary Imaging Catheter, Scout Imaging Catheter Patient T

- Pathway: 510(k) (Traditional)
- Applicant: Hewlett-Packard Co.
- Decided: Jul 14, 1998 after 231 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: 1 generation back to K921879 (1992). 4 ancestors in all.
32 later devices descend from it; 1 cites it directly.
1 of 37 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K942231: Microview II/Microrail II Catheters, Cardiovascular Imaging Systems, Inc. (1994) Summary page 1.
- K913890: Sonicath (TM) 3.5 F, 20 MHZ, Boston Scientific Corp (1992) Summary page 1.
- K933517: Automatic Pull Back Device, Cardiovascular Imaging Systems, Inc. (1993) Summary page 1.
- K921879: Cbis Catheter Pull-Back Device, Cardiovascular Imaging Systems, Inc. (1992) Summary page 1.

## Most influential descendants
- K050995: Revolution 45 MHZ Rotational Ivus Imaging Catheter (2005), 31 descendants of its own
- K071554: Volcano S5/S5I Intravascular Imaging and Pressure System (2008), 28 descendants of its own
- K082229: S5/S5I Series Intravascular Imaging and Pressure System, Combomap Pressure and Flow System (2008), 25 descendants of its own
- K111706: Volcano S5IINTRAVASCULAR Imaging and Pressure System (2011), 24 descendants of its own
- K123898: Volcano S5/S5I Intravascular Ultrasound Imaging and Pressure System (2013), 21 descendants of its own

## Indications for use
The Scout catheter is intended for the intravascular ultrasound examination of coronary arteries. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures.

Source page: https://510kreport.com/device/K974457
Methodology: https://510kreport.com/methodology