iLAB

md

ivd

ivd

Model Numbers M0004EPiL120CART0, serial number 4037; H749iLab120CART0, serial numbers 4041, 4020, 4056, 4018, 4037; H749iLab120CARTD0, serial number 4064; H749iLab120CARTR0, serial number 4022; H749iLab120INS0, serial numbers 4016, 4015, 4008, 4043.

Cardiovascular Devices

2

No

Product was distributed to 13 US consignees and 10 foreign consignees.

iLab Utrasound Imaging System, software controlled Imaging Catheter.

All serial numbers.

Cardiovascular Devices

2

No

Nationwide and Portugal.

Boston Scientific brand iLab¿ Ultrasound Imaging System, for intravascular use; || Model Number(s): iLab120lNS, iLab2401NS, || Distributed by and Manufactured by: || Boston Scientific Corporation IVUS, Technology Center, || 47201 lakeview Parkway, Fremont, CA 94538