510(k) K253111

Aeka Imaging by Good Methods Global, Inc. — Product Code LLZ

K253111 is an FDA 510(k) premarket notification submitted by Good Methods Global, Inc. for the device "Aeka Imaging". The FDA issued a decision of Substantially Equivalent on Mar 13, 2026. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Mar 13, 2026
Date Received
Sep 24, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Image Processing, Radiological
Device Class
Class II
Regulation Number
892.2050
Review Panel
RA
Submission Type