Cleared Traditional

HyperVue? Imaging System - Integrated

K253101 · Spectrawave, Inc. · Cardiovascular

Dec 2025

Decision

82d

Days

Class 2

Risk

About This 510(k) Submission

K253101 is an FDA 510(k) clearance for the HyperVue? Imaging System - Integrated, 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 December 15, 2025, 82 days after receiving the submission on September 24, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 892.1560.

Submission Details

510(k) Number	K253101 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 24, 2025
Decision Date	December 15, 2025
Days to Decision	82 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.