FDA 510(k)

Lunar Astra

Número K: K252718 · 2026-04-20

RequerenteGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC

Data da decisão2026-04-20

Código do produtoKGI

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

Lunar Astra 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 2026-04-20 under 510(k) number K252718. The device is classified under product code KGI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Lunar Astra?

Lunar Astra is a medical device that received FDA 510(k) clearance on 2026-04-20. The listed applicant is GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC. The 510(k) number is K252718.

When did Lunar Astra receive FDA 510(k) clearance?

Lunar Astra received FDA 510(k) clearance on 2026-04-20, under 510(k) number K252718.

Who is the listed applicant for Lunar Astra?

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 Lunar Astra?

The FDA product code for Lunar Astra is KGI.

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Fonte oficial

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