Radiology · 510(k) · 2025
X1-FFR
Spectrawave, Inc.. Cleared by FDA on 17 October 2025 under submission K251355, product code QHA (x-ray angiographic imaging based coronary vascular simulation software device). What FDA's record says, in FDA's words.
Device record · K251355
- Device. X1-FFRDEVICE
- Company. Spectrawave, Inc.COMPANY
- Decision. 17 October 2025, 510(k), substantially equivalent (traditional review); received 30 April 2025DECISION
- Panel. RadiologyPANEL
- Product code. QHA, X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software DeviceCODE
- Regulation. 21 CFR 892.1600, Class IIREG
- Source. FDA database entry · decision document (11 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
The Spectra WA VE Xl-FFR Software features segmentation of coronary vessels, and measurement and reporting tools to facilitate the following use: • Calculate the dimensions of coronary vessels; • Quantify stenosis in coronary vessels; • Quantify pressure drop in coronary vessels; The Spectra WA VE Xl-FFR Software is intended to be used by or under the supervision of a cardiologist.
The product code's definition, from FDA's classification record. 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 the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Mentionsmeasurement or quantification
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 0 reports filed against devices carrying product code QHA. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code QHA, in Radiology, or cleared in 2025. The whole record is at FDA AI-enabled medical devices.
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