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FDA 510(k)

AngioWaveNet

K-Number: K244002 · 2025-09-10

ApplicantAngiowave Imaging, Inc.
Decision Date2025-09-10
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AngioWaveNet is a medical device manufactured by Angiowave Imaging, Inc.. It received FDA 510(k) clearance on 2025-09-10 under approval number K244002. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AngioWaveNet?

AngioWaveNet is a medical device that received FDA 510(k) clearance on 2025-09-10. It is manufactured by Angiowave Imaging, Inc.. The 510(k) number is K244002.

When was AngioWaveNet approved by the FDA?

AngioWaveNet received FDA 510(k) clearance on 2025-09-10, under approval number K244002.

What company makes AngioWaveNet?

AngioWaveNet is manufactured by Angiowave Imaging, Inc..

What is the FDA product code for AngioWaveNet?

The FDA product code for AngioWaveNet is QIH.

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Official Source

View on FDA Database →

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