Cleared Traditional

HyperVue? Software

K251198 · Spectrawave, Inc. · Cardiovascular

Jul 2025

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K251198 is an FDA 510(k) clearance for the HyperVue? Software, a System, Imaging, Optical Coherence Tomography (oct) (Class II — Special Controls, product code NQQ), submitted by Spectrawave, Inc. (Bedford, US). The FDA issued a Cleared decision on July 16, 2025, 90 days after receiving the submission on April 17, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 892.1560.

Submission Details

510(k) Number	K251198 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 17, 2025
Decision Date	July 16, 2025
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	NQQ — System, Imaging, Optical Coherence Tomography (oct)
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 892.1560
Definition	This Device Uses Back-reflected Light To Create Two-dimensional Images Versus Back-reflected Sound Waves As Are Used In Ultrasound Imaging.