Cleared Traditional

K161756 - SyncVision System
(FDA 510(k) Clearance)

K161756 · Volcano Corporation · Radiology

Sep 2016

Decision

70d

Days

Class 2

Risk

K161756 is an FDA 510(k) clearance for the SyncVision System. This device is classified as 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 September 5, 2016, 70 days after receiving the submission on June 27, 2016.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1650. Interventional Fluoroscopy.

Submission Details

510(k) Number	K161756 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 27, 2016
Decision Date	September 05, 2016
Days to Decision	70 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