OPTIMA XR120

Device, Spot-film

GE MEDICAL SYSTEMS, LLC

The following data is part of a premarket notification filed by Ge Medical Systems, Llc with the FDA for Optima Xr120.

Pre-market Notification Details

Device IDK111304
510k NumberK111304
Device Name:OPTIMA XR120
ClassificationDevice, Spot-film
Applicant GE MEDICAL SYSTEMS, LLC 3000 N GRANDVIEW BLVD. Waukesha,  WI  53188
ContactNidhi Chaudhary
CorrespondentNidhi Chaudhary
GE MEDICAL SYSTEMS, LLC 3000 N GRANDVIEW BLVD. Waukesha,  WI  53188
Product CodeIXL  
CFR Regulation Number892.1670 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-05-09
Decision Date2011-07-19
Summary:summary

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