Devices · Spectrawave, Inc.

X1-FFR

Spectrawave, Inc. is listed for X1-FFR (K251355). The FDA list gives October 17, 2025 as the date of the final decision. The lead panel is Radiology, and the database link on the FDA list is the 510(k) pathway. openFDA describes product code QHA as “X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device”: 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. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251355

Official FDA database record

Date of final decision

October 17, 2025

Company on the FDA list

Spectrawave, Inc.

Lead panel

Radiology

Primary product code

QHA

openFDA device name for the code

X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device

Device class

2

Regulation number

892.1600

openFDA decision description

Substantially Equivalent

openFDA decision code

SESE

Statement or summary label

Summary