Medical Device Manufacturer · US , Bedford , MA

Spectrawave, Inc. - FDA 510(k) Cleared Devices

6 submissions · 6 cleared · Since 2023

Recent clearances: HyperVue™ Imaging System - Integrated, X1-FFR, HyperVue™ Software

6

Total

6

Cleared

0

Denied

FDA 510(k) Regulatory Record - Spectrawave, Inc. Cardiovascular ✕

5 devices

1-5 of 5

Cleared Dec 15, 2025

HyperVue™ Imaging System - Integrated

Cardiovascular · 82d

Cleared Jul 16, 2025

HyperVue™ Software

Cardiovascular · 90d

Cleared Mar 20, 2025

Starlight Imaging Catheter

Cardiovascular · 174d

Cleared Jun 07, 2023

HyperVue™ Imaging System

Cardiovascular · 86d

Cleared Feb 28, 2023

SpectraWAVE Imaging System

Cardiovascular · 302d