AngioWaveNet— 510(k) K244002

Substantially Equivalent

Angiowave Imaging, Inc.

FDA 510(k) clearance K244002 for AngioWaveNet, Substantially Equivalent on 2025-09-10. Applicant: Angiowave Imaging, Inc.. Device class: 2.

Clearance details

Applicant: Angiowave Imaging, Inc.
Product code: Code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2024-12-26
Decision date: 2025-09-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Concord, MA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.