FDA 510(k)

X1-FFR

K-Number: K251355 · 2025-10-17

Decision Date2025-10-17

Product CodeQHA

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

X1-FFR is the device name listed in this FDA 510(k) record. The listed applicant is Spectrawave, Inc.. It received FDA 510(k) clearance on 2025-10-17 under 510(k) 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. The listed applicant is Spectrawave, Inc.. The 510(k) number is K251355.

When did X1-FFR receive FDA 510(k) clearance?

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

Who is the listed applicant for X1-FFR?

The FDA 510(k) record lists Spectrawave, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for X1-FFR?

The FDA product code for X1-FFR is QHA.

Other records listing Spectrawave, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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

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Official Source

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