Class Class II

HyperVue™ Imaging System – Integrated (K253101)

K253101 2025-12-15 Traditional
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Description

HyperVue™ Imaging System - Integrated by Spectrawave, Inc., an FDA 510(k) cleared radiology device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK253101
Clearance Date2025-12-15
Clearance TypeTraditional
Product CodeNQQ
Regulation Number892.1560

Categories

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