iLab Ultrasound Imaging System / Boston Scientific Corporation / Smith Senior Regulatory Affairs Specialist Boston Scientific Corp. / 2 Boston Scienitific Boston Scientific Corporation / Effectiveness Boston Scientific Corporation / In Vitro Diagnostics / Radiological Health Enclosure Boston Scientific Corporation / K130243 Trade / / /
Event
FDA Phase / /
Facility
New Hampshire Avenue Document Control Center / / /
IndustryTerm
basic diagnostic tool / real time viewing / announcements concerning your device / predicate device / manufacturing practice requirements / Internet address http2 /
MedicalTreatment
CPR / angioplasty / atherectomy / /
Organization
Radiological Health Office / Division of Postmarket Surveillance / Food and Drug Administration / Center for Devices and Radiological Health / office of Compliance / CDRH 's office of Surveillance / New Hampshire Avenue Document Control Center / /
Person
Lori R. Smith Sr. / Janine Morris / / /
Position
Sr. Regulatory Affairs Specialist / Director / Division / iLabTM Ultrasound Imaging System General Information Manufacturer / /
Product
Federal Food / /
ProvinceOrState
Maryland / California / /
Technology
Design verification / radiation / Diagnostic Imaging System / Ultrasound / same fundamental scientific technology / /