Spectrawave, Inc. - FDA 510(k) Cleared Devices
6
Total
6
Cleared
0
Denied
Spectrawave, Inc. has 6 FDA 510(k) cleared medical devices. Based in Bedford, US.
Latest FDA clearance: Dec 2025. Active since 2023. Primary specialty: Cardiovascular.
Browse the FDA 510(k) cleared devices submitted by Spectrawave, Inc. Filter by specialty or product code using the sidebar.
FDA 510(k) cleared devices by Spectrawave, Inc.
6 devices
Cleared
Dec 15, 2025
HyperVue™ Imaging System - Integrated
Cardiovascular
82d
Cleared
Oct 17, 2025
X1-FFR
Radiology
170d
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