Aeka Imaging— 510(k) K253111

Name: FDA 510(k) clearance K253111
Creator: U.S. Food and Drug Administration
Published: 2026-03-13

Substantially Equivalent

Good Methods Global, Inc.

FDA 510(k) clearance K253111 for Aeka Imaging, Substantially Equivalent on 2026-03-13. Applicant: Good Methods Global, Inc.. Device class: 2.

Summary

Good Methods Global's Aeka Imaging is filed under LLZ, radiological image processing systems. The record doesn't describe the product beyond its name and that code name.

Class II, 21 CFR 892.2050. Radiology is both the classification panel and the review panel, and it came in as a Traditional 510(k).

Good Methods Global filed from Celebration, Florida. Review took 170 calendar days (September 24, 2025 to March 13, 2026).

Clearance details

Applicant: Good Methods Global, Inc.
Product code: Product code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2025-09-24
Decision date: 2026-03-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Celebration, FL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.