Cleared Traditional

Aeka Imaging

K253111 · Good Methods Global, Inc. · Radiology
Mar 2026
Decision
170d
Days
Class 2
Risk

About This 510(k) Submission

K253111 is an FDA 510(k) clearance for the Aeka Imaging, a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ), submitted by Good Methods Global, Inc. (Celebration, US). The FDA issued a Cleared decision on March 13, 2026, 170 days after receiving the submission on September 24, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K253111 FDA.gov
FDA Decision Cleared SESE
Date Received September 24, 2025
Decision Date March 13, 2026
Days to Decision 170 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code LLZ — System, Image Processing, Radiological
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.2050