Class Class II

X1-FFR (K251355)

K251355 2025-10-17 Traditional
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Description

X1-FFR by Spectrawave, Inc., an FDA 510(k) cleared radiology device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK251355
Clearance Date2025-10-17
Clearance TypeTraditional
Product CodeQHA
Regulation Number892.1600

Categories

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