Aeka Imaging

FDA 510(k) K253111 · Good Methods Global, Inc.

Substantially Equivalent

510(k) numberK253111

Submission

Device name
Aeka Imaging
Applicant
Good Methods Global, Inc.
Celebration, FL, US
Received
September 24, 2025
Decision date
March 13, 2026
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LLZ – System, Image Processing, Radiological
Device class
Class II (moderate risk)
Regulation
21 CFR 892.2050
Specialty
Radiology

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Questions and answers

When was Aeka Imaging cleared by the FDA?

Aeka Imaging (K253111) received a 510(k) decision of Substantially Equivalent on March 13, 2026, 170 days after the submission was received.

What is the product code of K253111?

The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.