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COMPANY

SpectraWAVE

HQ: Bedford, MA source · spectrawave.com ↗ · New England

FDA-cleared device company

Location: Bedford, MA · source · Oct 14, 2026

Profile checked Oct 10, 2026

4FDA records (2 yrs)

Timeline

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

FDA records (last 2 years)

Connect

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LinkedIn page linked from the company's own site: source · seen 2026-10-12

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