FDA 510(k)

HyperVue Software

K-Number: K251198 · 2025-07-16

Decision Date2025-07-16

Product CodeNQQ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

HyperVue Software is a medical device manufactured by Spectrawave, Inc.. It received FDA 510(k) clearance on 2025-07-16 under approval number K251198. The device is classified under product code NQQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HyperVue Software?

HyperVue Software is a medical device that received FDA 510(k) clearance on 2025-07-16. It is manufactured by Spectrawave, Inc.. The 510(k) number is K251198.

When was HyperVue Software approved by the FDA?

HyperVue Software received FDA 510(k) clearance on 2025-07-16, under approval number K251198.

What company makes HyperVue Software?

HyperVue Software is manufactured by Spectrawave, Inc..

What is the FDA product code for HyperVue Software?

The FDA product code for HyperVue Software is NQQ.

Other Devices by Spectrawave, Inc.

K230691HyperVue Imaging System K221257SpectraWAVE Imaging System K253101HyperVue Imaging System - Integrated K251355X1-FFR K243016Starlight Imaging Catheter

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Official Source

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