Class Class II

ANDI 2.0 (K252298)

K252298 2025-10-22 Traditional
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Description

ANDI 2.0 by Imeka Solutions, Inc., an FDA 510(k) cleared radiology device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK252298
Clearance Date2025-10-22
Clearance TypeTraditional
Product CodeQIH
Regulation Number892.2050

Categories

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