Cleared Traditional

C-QUEST

K992103 · Wuestec Medical, Inc. · Radiology

Sep 1999

Decision

71d

Days

Class 2

Risk

About This 510(k) Submission

K992103 is an FDA 510(k) clearance for the C-QUEST, a Interventional Fluoroscopic X-ray System (Class II — Special Controls, product code OWB), submitted by Wuestec Medical, Inc. (Mobile, US). The FDA issued a Cleared decision on September 1, 1999, 71 days after receiving the submission on June 22, 1999. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1650.

Submission Details

510(k) Number	K992103 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 22, 1999
Decision Date	September 01, 1999
Days to Decision	71 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Statement

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