Aria
K-Number: K180782 · 2018-04-20
Decision Date2018-04-20
Product CodeKGI
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Aria is a medical device manufactured by GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC. It received FDA 510(k) clearance on 2018-04-20 under approval number K180782. The device is classified under product code KGI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Aria?
Aria is a medical device that received FDA 510(k) clearance on 2018-04-20. It is manufactured by GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC. The 510(k) number is K180782.
When was Aria approved by the FDA?
Aria received FDA 510(k) clearance on 2018-04-20, under approval number K180782.
What company makes Aria?
Aria is manufactured by GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC.
What is the FDA product code for Aria?
The FDA product code for Aria is KGI.
Other Devices by GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC
Related Devices (Code: KGI)
K161682GE Lunar DXA Bone Densitometers with enCORE version 17GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC
K152299TBS iNsightMedimaps Group SA
K191112GEHC DXA Bone Densitometers with enCORE version 18GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC
K2208223D-SHAPER3D-Shaper Medical S.L
K213760ABMD SoftwareHeartLung Corporation
K220402VirtuOstO.N. Diagnostics
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.