Cleared Traditional

SyncVision System

K172574 · Volcano Corporation · Radiology

Oct 2017

Decision

38d

Days

Class 2

Risk

About This 510(k) Submission

K172574 is an FDA 510(k) clearance for the SyncVision System, a Interventional Fluoroscopic X-ray System (Class II — Special Controls, product code OWB), submitted by Volcano Corporation (San Diego, US). The FDA issued a Cleared decision on October 5, 2017, 38 days after receiving the submission on August 28, 2017. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1650.

Submission Details

510(k) Number	K172574 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 28, 2017
Decision Date	October 05, 2017
Days to Decision	38 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF

Device Classification

Product Code	OWB — Interventional Fluoroscopic X-ray System
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 892.1650
Definition	Interventional Fluoroscopy