Cleared Traditional

XRT 400

K955414 · Wuestec Medical, Inc. · Radiology
Jul 1996
Decision
240d
Days
Class 2
Risk

About This 510(k) Submission

K955414 is an FDA 510(k) clearance for the XRT 400, a Table, Radiologic (Class II — Special Controls, product code KXJ), submitted by Wuestec Medical, Inc. (Mobile, US). The FDA issued a Cleared decision on July 24, 1996, 240 days after receiving the submission on November 27, 1995. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1980.

Submission Details

510(k) Number K955414 FDA.gov
FDA Decision Cleared SESE
Date Received November 27, 1995
Decision Date July 24, 1996
Days to Decision 240 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement

Device Classification

Product Code KXJ — Table, Radiologic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1980