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FDA 510(k)

X1-FFR

K-Number: K251355 · 2025-10-17

ApplicantSpectrawave, Inc.
Decision Date2025-10-17
Product CodeQHA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

X1-FFR is a medical device manufactured by Spectrawave, Inc.. It received FDA 510(k) clearance on 2025-10-17 under approval number K251355. The device is classified under product code QHA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the X1-FFR?

X1-FFR is a medical device that received FDA 510(k) clearance on 2025-10-17. It is manufactured by Spectrawave, Inc.. The 510(k) number is K251355.

When was X1-FFR approved by the FDA?

X1-FFR received FDA 510(k) clearance on 2025-10-17, under approval number K251355.

What company makes X1-FFR?

X1-FFR is manufactured by Spectrawave, Inc..

What is the FDA product code for X1-FFR?

The FDA product code for X1-FFR is QHA.

Other Devices by Spectrawave, Inc.

K230691HyperVue™ Imaging System K221257SpectraWAVE Imaging System K253101HyperVue™ Imaging System - Integrated K251198HyperVue™ Software K243016Starlight Imaging Catheter

Related Devices (Code: QHA)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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