ANDI 2.2— 510(k) K261405

Substantially Equivalent

Imeka Solutions, Inc.

FDA 510(k) clearance K261405 for ANDI 2.2, Substantially Equivalent on 2026-05-28. Applicant: Imeka Solutions, Inc..

Clearance details

Applicant
Imeka Solutions, Inc.
Product code
Code QIH
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Sherbrooke, CA
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