Cleared Traditional

SyncVision System

K190626 · Volcano Corporation · Radiology

Apr 2019

Decision

32d

Days

Class 2

Risk

About This 510(k) Submission

K190626 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 April 12, 2019, 32 days after receiving the submission on March 11, 2019. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1650.

Submission Details

510(k) Number	K190626 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 11, 2019
Decision Date	April 12, 2019
Days to Decision	32 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