Cleared Traditional

MODEL ALPHA TS-2

K935004 · Dpa Consulting, Inc. · Radiology

Dec 1993

Decision

55d

Days

Class 1

Risk

About This 510(k) Submission

K935004 is an FDA 510(k) clearance for the MODEL ALPHA TS-2, a Tube Mount, X-ray, Diagnostic (Class I — General Controls, product code IYB), submitted by Dpa Consulting, Inc. (Urbanna, US). The FDA issued a Cleared decision on December 13, 1993, 55 days after receiving the submission on October 19, 1993. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1770.

Submission Details

510(k) Number	K935004 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 19, 1993
Decision Date	December 13, 1993
Days to Decision	55 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Statement