# K063493: I Review Software (Accessory to) Ilab Ultrasound Imaging System) VERSION1.0

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corp
- Decided: Dec 21, 2006 after 31 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- 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.
No later device cites it as a predicate yet.
0 of 6 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) Summary page 2.

## Recalls of this device
- May 2, 2008 · Not classified · Z-2006-2008: The firm initiated a recall of a specific iReview" Software, Ver 1.0 Kit, which was released for distribution in a non-validated format.

## Indications for use
The iLab TM 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. The iReview Software accessory does not change the iLab indications for use.

Source page: https://510kreport.com/device/K063493
Methodology: https://510kreport.com/methodology