Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic Ultrasound System

System, Imaging, Pulsed Doppler, Ultrasonic

GE MEDICAL SYSTEMS ISRAEL LTD.

The following data is part of a premarket notification filed by Ge Medical Systems Israel Ltd. with the FDA for Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic Ultrasound System.

Pre-market Notification Details

Device IDK142323
510k NumberK142323
Device Name:Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic Ultrasound System
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant GE MEDICAL SYSTEMS ISRAEL LTD. 4 Etgar Street Tirat Carmel,  IL 39120
ContactBryan Behn
CorrespondentBryan Behn
GE Healthcare 9900 Innovation Drive 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 Received2014-08-20
Decision Date2014-10-10
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00840682120128 K142323 000
00840682115650 K142323 000
00840682115582 K142323 000
00840682111966 K142323 000
00840682110976 K142323 000
00840682105316 K142323 000

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