ANDI 2.0— 510(k) K252298

Substantially Equivalent

Imeka Solutions, Inc.

FDA 510(k) clearance K252298 for ANDI 2.0, Substantially Equivalent on 2025-10-22. Applicant: Imeka Solutions, Inc..

Clearance details

Applicant: Imeka Solutions, Inc.
Product code: Code QIH
Advisory panel: Radiology
Date received: 2025-07-23
Decision date: 2025-10-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sherbrooke, CA

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