Cleared Traditional

SpectraWAVE Imaging System

K221257 · Spectrawave, Inc. · Cardiovascular

Feb 2023

Decision

302d

Days

Class 2

Risk

About This 510(k) Submission

K221257 is an FDA 510(k) clearance for the SpectraWAVE 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 February 28, 2023, 302 days after receiving the submission on May 2, 2022. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 892.1560.

Submission Details

510(k) Number	K221257 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 02, 2022
Decision Date	February 28, 2023
Days to Decision	302 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.