Cleared Traditional

MOVABLE CANTILEVERED RADIOGRAPHIC TABLE XRT 100, 200 & 300

K960083 · Wuestec Medical, Inc. · Radiology
Jul 1996
Decision
195d
Days
Class 2
Risk

About This 510(k) Submission

K960083 is an FDA 510(k) clearance for the MOVABLE CANTILEVERED RADIOGRAPHIC TABLE XRT 100, 200 & 300, a Table, Radiographic, Stationary Top (Class II — Special Controls, product code IXQ), submitted by Wuestec Medical, Inc. (Mobile, US). The FDA issued a Cleared decision on July 24, 1996, 195 days after receiving the submission on January 11, 1996. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1980.

Submission Details

510(k) Number K960083 FDA.gov
FDA Decision Cleared SESE
Date Received January 11, 1996
Decision Date July 24, 1996
Days to Decision 195 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement

Device Classification

Product Code IXQ — Table, Radiographic, Stationary Top
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1980