Cleared Traditional

K251355 - X1-FFR

K251355 is an FDA 510(k) clearance for X1-FFR, manufactured by Spectrawave, Inc.. The device is a Class 2 Radiology device with product code QHA cleared through the Traditional 510(k) pathway after a 170-day FDA review.

K251355 · Spectrawave, Inc. · Radiology device
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Oct 2025
Decision
170d
Days
Class 2
Risk

K251355 is an FDA 510(k) clearance for the X1-FFR. Classified as X-ray Angiographic Imaging Based Coronary Vascular Simulation Software Device (product code QHA), Class II - Special Controls.

Submitted by Spectrawave, Inc. (Bedford, US). The FDA issued a Cleared decision on October 17, 2025 after a review of 170 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1600 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Spectrawave, Inc. devices

FDA 510(k) Submission Details - K251355

510(k) Number K251355 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 2025
Decision Date October 17, 2025
Days to Decision 170 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
63d slower than avg
Panel avg: 107d · This submission: 170d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

QHA Device Classification - Class 2, Special Controls

Product Code QHA X-ray Angiographic Imaging Based Coronary Vascular Simulation Software Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1600
Definition X-ray Angiographic Imaging Based Coronary Vascular Simulation Software Device Is A Prescription Device That Provides An Image Analysis Tool To Assess Blood Flow In The Coronary Vascular System Using X-ray Angiographic Imaging Data. X-ray Angiographic Imaging Based Coronary Vascular Simulation Software Device Solves Algorithms And Yields Simulation-based Metrics For Certain Cardiology Applications. X-ray Angiographic Imaging Based Coronary Vascular Simulation Software Device Cannot Be Used Alone For Clinical Decision Making And Clinical Management, And Is A Tool Intended To Generate Results For Use And Review By A Qualified Clinician.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

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