Vivid Iq

System, Imaging, Pulsed Doppler, Ultrasonic

GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIAGNOSTICS L

The following data is part of a premarket notification filed by Ge Medical Systems Ultrasound And Primary Care Diagnostics L with the FDA for Vivid Iq.

Pre-market Notification Details

Device IDK161706
510k NumberK161706
Device Name:Vivid Iq
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIAGNOSTICS L 9900 W. INNOVATION DR. Wauwatosa,  WI  53226
ContactTracey Ortiz
CorrespondentTracey Ortiz
GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIAGNOSTICS L 9900 W. INNOVATION DR. Wauwatosa,  WI  53226
Product CodeIYN  
Subsequent Product CodeITX
Subsequent Product CodeIYO
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-06-20
Decision Date2016-08-05
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00840682119283 K161706 000
00840682117883 K161706 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.