# K170385: CORE M2 Vascular System

- Pathway: 510(k) (Special)
- Applicant: Volcano Corporation
- Decided: Apr 6, 2017 after 57 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: 12 generations back to K934139 (1995). 52 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 54 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153369: SW v3.5 Install Kit, CORE Mobile, SW v3.5 Install Kit, CORE, SW v3.5 Install Kit, s5iz, Volcano Corporation (2015) Summary page 4.

## Most influential descendants
- K172455: CORE M2 Vascular System, CORE M2 Software v4.2 Upgrade Kit, CORE M2 Software v4.2 Installation Kit (2017), 0 descendants of its own

## Indications for use
The CORE M2 Vascular System 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.

Source page: https://510kreport.com/device/K170385
Methodology: https://510kreport.com/methodology