Optima XR200amx, Optima XR220amx

System, X-ray, Mobile

GE Medical Systems, LLC

The following data is part of a premarket notification filed by Ge Medical Systems, Llc with the FDA for Optima Xr200amx, Optima Xr220amx.

Pre-market Notification Details

Device IDK142383
510k NumberK142383
Device Name:Optima XR200amx, Optima XR220amx
ClassificationSystem, X-ray, Mobile
Applicant GE Medical Systems, LLC 3000 N. Grandview Blvd. Waukesha,  WI  53188
ContactChris Paulik
CorrespondentChris Paulik
GE Medical Systems, LLC 3000 N. Grandview Blvd. Waukesha,  WI  53188
Product CodeIZL  
CFR Regulation Number892.1720 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-08-26
Decision Date2014-09-25
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00840682119658 K142383 000
00840682115278 K142383 000
00840682115261 K142383 000

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