Cleared Traditional

SURGICAL C-ARM TABLE, 9610

K953557 · U.S. Imaging Tables, Inc. · Radiology

Sep 1995

Decision

71d

Days

Class 2

Risk

About This 510(k) Submission

K953557 is an FDA 510(k) clearance for the SURGICAL C-ARM TABLE, 9610, 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 review panel. Regulated under 21 CFR 892.1980.

Submission Details

510(k) Number	K953557 FDA.gov
FDA Decision	Cleared 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