# K072517: Ilab Ultrasound Imaging System, Version 1.3

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corp
- Decided: Sep 26, 2007 after 19 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K921750 (1992). 5 ancestors in all.
28 later devices descend from it; 1 cites 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)
- K051679: Ilab Ultrasound Imaging System, Boston Scientific Corp (2005). Our reading of the summary gave K051579, FDA’s number for Immunalysis Amphetamine Elisa for Oral Fluids (Immunalysis Corporation). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “iLab Intravascular Ultrasound System”. Summary page 11.

## Most influential descendants
- K123535: Ilab Ultrasound Imaging System (2013), 27 descendants of its own
- K130243: Ilab Ultrasound Imaging System (2013), 26 descendants of its own
- 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

## Recalls of this device
- Apr 11, 2000 · Not classified · Z-1693-2008: Improperly terminated wires on a component of the iLab Acquisition processor power supply could cause the processor to lock-up or stop, and prolong the patients procedure.

## 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/K072517
Methodology: https://510kreport.com/methodology