Cleared Traditional

ELECTROPHYSIOLOGY TILT TABLE MODEL #9660

K965105 · U.S. Imaging Tables, Inc. · Radiology

Jan 1997

Decision

41d

Days

Class 2

Risk

About This 510(k) Submission

K965105 is an FDA 510(k) clearance for the ELECTROPHYSIOLOGY TILT TABLE MODEL #9660, 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 30, 1997, 41 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	K965105 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 20, 1996
Decision Date	January 30, 1997
Days to Decision	41 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF