# K130243: Ilab Ultrasound Imaging System

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corp
- Decided: Mar 1, 2013 after 29 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: 5 generations back to K921750 (1992). 7 ancestors in all.
26 later devices descend from it; 4 cite it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123535: Ilab Ultrasound Imaging System, Boston Scientific Corp (2013) Summary page 1.

## Most influential descendants
- K170948: AcQMap High Resolution Imaging and Mapping System (2017), 11 descendants of its own
- K151613: iLab Polaris Multi-Modality Guidance System (2015), 10 descendants of its own
- K190131: AcQMap High Resolution Imaging and Mapping System (2019), 9 descendants of its own
- K191392: AcQMap High Resolution Imaging and Mapping System (2019), 8 descendants of its own
- K191008: iLab Polaris Multi-Modality Guidance System (2019), 8 descendants of its own

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

Source page: https://510kreport.com/device/K130243
Methodology: https://510kreport.com/methodology