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FDA 510(k)

Aria

K-Number: K180782 · 2018-04-20

ApplicantGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC
Decision Date2018-04-20
Product CodeKGI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Aria is the device name listed in this FDA 510(k) record. The listed applicant is GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC. It received FDA 510(k) clearance on 2018-04-20 under 510(k) 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. The listed applicant is GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC. The 510(k) number is K180782.

When did Aria receive FDA 510(k) clearance?

Aria received FDA 510(k) clearance on 2018-04-20, under 510(k) number K180782.

Who is the listed applicant for Aria?

The FDA 510(k) record lists GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Aria?

The FDA product code for Aria is KGI.

Other records listing GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: KGI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252718Lunar AstraGE Medical Systems Ultrasound & Primary Care Diagnostics, LLCK2510223D-SHAPER3D-Shaper Medical S.LK242295BunkerHill BMDBunkerHill HealthK243218TBS iNsight (V4)Medimaps Group SAK220402VirtuOstO.N. DiagnosticsK2208223D-SHAPER3D-Shaper Medical S.L

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.

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