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Spectrawave, Inc.

6 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
HyperVue™ Imaging System - Integrated (K253101)Spectrawave, Inc.2025-12-15
X1-FFR (K251355)Spectrawave, Inc.2025-10-17
HyperVue™ Software (K251198)Spectrawave, Inc.2025-07-16
Starlight Imaging Catheter (K243016)Spectrawave, Inc.2025-03-20
HyperVue™ Imaging System (K230691)Spectrawave, Inc.2023-06-07
SpectraWAVE Imaging System (K221257)Spectrawave, Inc.2023-02-28

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Every clearance here is in the API, with alerts when new ones post.