COMPANY
SpectraWAVE
Timeline
- FDA FDA 510(k) clearance: HyperVue Imaging System - Integrated — K253101, Dec 15, 2025. Applicant at approval: Spectrawave, Inc. source ↗
- FDA FDA 510(k) clearance: X1-FFR — K251355, Oct 17, 2025. Applicant at approval: Spectrawave, Inc. source ↗
- FDA FDA 510(k) clearance: HyperVue Software — K251198, Jul 16, 2025. Applicant at approval: Spectrawave, Inc. source ↗
- FDA FDA 510(k) clearance: Starlight Imaging Catheter — K243016, Mar 20, 2025. Applicant at approval: Spectrawave, Inc. source ↗
FDA records (last 2 years)
- FDA 510(k) clearance: HyperVue Imaging System - Integrated — K253101, Dec 15, 2025. Applicant at approval: Spectrawave, Inc. source ↗
- FDA 510(k) clearance: X1-FFR — K251355, Oct 17, 2025. Applicant at approval: Spectrawave, Inc. source ↗
- FDA 510(k) clearance: HyperVue Software — K251198, Jul 16, 2025. Applicant at approval: Spectrawave, Inc. source ↗
- FDA 510(k) clearance: Starlight Imaging Catheter — K243016, Mar 20, 2025. Applicant at approval: Spectrawave, Inc. source ↗
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