# K152316: iLab Ultrasound Imaging System

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific
- Decided: Sep 18, 2015 after 32 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: 6 generations back to K921750 (1992). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130243: Ilab Ultrasound Imaging System, Boston Scientific Corp (2013) Summary page 5.

## Most influential descendants
- K250684: OPUSWAVE Dual Sensor Imaging System (2025), 0 descendants of its own

## Indications for use
The iLab Ultrasound Imaging System is intended for ultrasound examinations of intravascular pathology. Intravascular ultrasound is indicated for patients who are are candidates for transluminal interventional procedures such as angioplasty and atherectomy.

Source page: https://510kreport.com/device/K152316
Methodology: https://510kreport.com/methodology