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FDA 510(k)

Aurora

K-Number: K251153 · 2025-06-12

ApplicantGe Medical Systems Israel
Decision Date2025-06-12
Product CodeKPS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Aurora is a medical device manufactured by Ge Medical Systems Israel. It received FDA 510(k) clearance on 2025-06-12 under approval number K251153. 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 2025-06-12. It is manufactured by Ge Medical Systems Israel. The 510(k) number is K251153.

When was Aurora approved by the FDA?

Aurora received FDA 510(k) clearance on 2025-06-12, under approval number K251153.

What company makes Aurora?

Aurora is manufactured by Ge Medical Systems Israel.

What is the FDA product code for Aurora?

The FDA product code for Aurora is KPS.

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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.

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