# K051679: Ilab Ultrasound Imaging System

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corp
- Decided: Jul 14, 2005 after 21 days
- Product code: OBJ (Catheter, Ultrasound, Intravascular)
- Device class: 2
- Regulation: 21 CFR 870.1200
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K921750 (1992). 4 ancestors in all.
36 later devices descend from it; 5 cite it directly.
1 of 41 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980851: Galaxy Intravascular Ultrasound System, Model I5028, Boston Scientific Corp (1998) Summary page 1.

## Most influential descendants
- K072517: Ilab Ultrasound Imaging System, Version 1.3 (2007), 28 descendants of its own
- 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

## Recalls of this device
- Dec 1, 2006 · Not classified · Z-0395-2007: The product fails to comply with applicable electronic product performance standard, in that the electromagnetic energy is in excess of the labeled conformance standards for radiated emissions.
- Mar 6, 2006 · Not classified · Z-0789-06: Using the product for procedures that exceed manual record mode may result in inadvertent needle stick to myocardium or blood vessel. (with ICE intracardiac imaging catheters only)

## Indications for use
The iLabTM Ultrasound Imaging Systemr 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/K051679
Methodology: https://510kreport.com/methodology