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FDA-cleared K244002

AngioWaveNet

Angiowave Imaging, Inc.

Authorized purpose: AngioWaveNet aids qualified physicians in analyzing and interpreting X-ray coronary angiographic cine images in adults by enhancing visibility of blood vessels, vascular structures, and related anatomy as a complement to standard angiographic cines.

Modality
Fluoroscopy/Angiography
Anatomy
Heart/coronary arteries
Decision
2025-09-10