Imeka Solutions, Inc.

Name: AI Device Index: FDA-listed AI-enabled medical devices
Creator: AI Device Index
License: https://creativecommons.org/licenses/by/4.0/

3 AI-enabled medical devices from Imeka Solutions, Inc. on FDA's AI-enabled device list, newest first. Includes filings under name variants as submitted to FDA.

Decision	Number	Device	Company	Panel
2026-05-28	K261405	ANDI 2.2	Imeka Solutions, Inc.	Radiology
2025-10-22	K252298	ANDI 2.0	Imeka Solutions, Inc.	Radiology
2023-07-25	K230913	ANDI	Imeka Solutions, Inc.	Radiology

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