Cleared Traditional

HyperVue? Imaging System

K230691 · Spectrawave, Inc. · Cardiovascular

Jun 2023

Decision

86d

Days

Class 2

Risk

About This 510(k) Submission

K230691 is an FDA 510(k) clearance for the HyperVue? Imaging System, 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 June 7, 2023, 86 days after receiving the submission on March 13, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 892.1560.

Submission Details

510(k) Number	K230691 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 13, 2023
Decision Date	June 07, 2023
Days to Decision	86 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.