Class Class II

MR DWI/FLAIR Measurement V1.0 (K230552)

K230552 2023-04-26 Traditional
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Description

MR DWI/FLAIR Measurement V1.0 by Olea Medical — FDA 510(k) cleared radiology device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK230552
Clearance Date2023-04-26
Clearance TypeTraditional
Product CodeLLZ
Regulation Number892.2050

Categories

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