Cleared Traditional

K941004 - CTS SYSTEM
(FDA 510(k) Clearance)

K941004 · Acoma Medical Imaging, Inc. · Radiology device

Jul 1994

Decision

150d

Days

Class 1

Risk

K941004 is an FDA 510(k) clearance for the CTS SYSTEM. This device is classified as a Tube Mount, X-ray, Diagnostic (Class I - General Controls, product code IYB).

Submitted by Acoma Medical Imaging, Inc. (Wheeling, US). The FDA issued a Cleared decision on July 29, 1994, 150 days after receiving the submission on March 1, 1994.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1770.

Submission Details

510(k) Number	K941004 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 01, 1994
Decision Date	July 29, 1994
Days to Decision	150 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF