Cleared Traditional

K953556 - VACS TABLE, 9650 (FDA 510(k) Clearance)

Sep 1995
Decision
71d
Days
Class 2
Risk

K953556 is an FDA 510(k) clearance for the VACS TABLE, 9650. This device is classified as a Table, Radiographic, Tilting (Class II - Special Controls, product code IXR).

Submitted by U.S. Imaging Tables, Inc. (Northport, US). The FDA issued a Cleared decision on September 26, 1995, 71 days after receiving the submission on July 17, 1995.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1980.

Submission Details

510(k) Number K953556 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 1995
Decision Date September 26, 1995
Days to Decision 71 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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