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FDA 510(k)

Aeka Imaging

K-Number: K253111 · 2026-03-13

ApplicantGood Methods Global, Inc.
Decision Date2026-03-13
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Aeka Imaging is a medical device manufactured by Good Methods Global, Inc.. It received FDA 510(k) clearance on 2026-03-13 under approval number K253111. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Aeka Imaging?

Aeka Imaging is a medical device that received FDA 510(k) clearance on 2026-03-13. It is manufactured by Good Methods Global, Inc.. The 510(k) number is K253111.

When was Aeka Imaging approved by the FDA?

Aeka Imaging received FDA 510(k) clearance on 2026-03-13, under approval number K253111.

What company makes Aeka Imaging?

Aeka Imaging is manufactured by Good Methods Global, Inc..

What is the FDA product code for Aeka Imaging?

The FDA product code for Aeka Imaging is LLZ.

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Official Source

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