Cleared Traditional

XRT 600 R/F, WRF 0600

K992603 · Wuestec Medical, Inc. · Radiology
Oct 1999
Decision
83d
Days
Class 2
Risk

About This 510(k) Submission

K992603 is an FDA 510(k) clearance for the XRT 600 R/F, WRF 0600, a System, X-ray, Fluoroscopic, Image-intensified (Class II — Special Controls, product code JAA), submitted by Wuestec Medical, Inc. (Mobile, US). The FDA issued a Cleared decision on October 25, 1999, 83 days after receiving the submission on August 3, 1999. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1650.

Submission Details

510(k) Number K992603 FDA.gov
FDA Decision Cleared SESE
Date Received August 03, 1999
Decision Date October 25, 1999
Days to Decision 83 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement

Device Classification

Product Code JAA — System, X-ray, Fluoroscopic, Image-intensified
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1650

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