Cleared Traditional

FLUOROVIEW SERIES FLUOROSCOPIC TABLES

K965096 · U.S. Imaging Tables, Inc. · Radiology
Jan 1997
Decision
38d
Days
Class 2
Risk

About This 510(k) Submission

K965096 is an FDA 510(k) clearance for the FLUOROVIEW SERIES FLUOROSCOPIC TABLES, a Table, Radiographic, Tilting (Class II — Special Controls, product code IXR), submitted by U.S. Imaging Tables, Inc. (Happauge, US). The FDA issued a Cleared decision on January 27, 1997, 38 days after receiving the submission on December 20, 1996. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1980.

Submission Details

510(k) Number K965096 FDA.gov
FDA Decision Cleared SESE
Date Received December 20, 1996
Decision Date January 27, 1997
Days to Decision 38 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code IXR — Table, Radiographic, Tilting
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1980

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