Lunar Astra
K-Number: K252718 · 2026-04-20
Decision Date2026-04-20
Product CodeKGI
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Lunar Astra is a medical device manufactured by GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC. It received FDA 510(k) clearance on 2026-04-20 under approval number K252718. 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 Lunar Astra?
Lunar Astra is a medical device that received FDA 510(k) clearance on 2026-04-20. It is manufactured by GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC. The 510(k) number is K252718.
When was Lunar Astra approved by the FDA?
Lunar Astra received FDA 510(k) clearance on 2026-04-20, under approval number K252718.
What company makes Lunar Astra?
Lunar Astra is manufactured by GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC.
What is the FDA product code for Lunar Astra?
The FDA product code for Lunar Astra is KGI.
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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.