ANDI— 510(k) K230913

Substantially Equivalent

Imeka Solutions, Inc.

FDA 510(k) clearance K230913 for ANDI, Substantially Equivalent on 2023-07-25. Applicant: Imeka Solutions, Inc..

Clearance details

Applicant: Imeka Solutions, Inc.
Product code: Code QIH
Advisory panel: Radiology
Date received: 2023-03-31
Decision date: 2023-07-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sherbrooke, CA

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