Aurora
K-Number: K243605 · 2025-01-17
Decision Date2025-01-17
Product CodeKPS
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Aurora is a medical device manufactured by Ge Medical Systems Israel, Functional Imaging. It received FDA 510(k) clearance on 2025-01-17 under approval number K243605. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Aurora?
Aurora is a medical device that received FDA 510(k) clearance on 2025-01-17. It is manufactured by Ge Medical Systems Israel, Functional Imaging. The 510(k) number is K243605.
When was Aurora approved by the FDA?
Aurora received FDA 510(k) clearance on 2025-01-17, under approval number K243605.
What company makes Aurora?
Aurora is manufactured by Ge Medical Systems Israel, Functional Imaging.
What is the FDA product code for Aurora?
The FDA product code for Aurora is KPS.
Other Devices by Ge Medical Systems Israel, Functional Imaging
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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.