Cleared Traditional

F/C/W TUBESTAND

K941017 · Acoma Medical Imaging, Inc. · Radiology
Jul 1994
Decision
148d
Days
Class 1
Risk

About This 510(k) Submission

K941017 is an FDA 510(k) clearance for the F/C/W TUBESTAND, 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, 148 days after receiving the submission on March 3, 1994. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1770.

Submission Details

510(k) Number K941017 FDA.gov
FDA Decision Cleared SESE
Date Received March 03, 1994
Decision Date July 29, 1994
Days to Decision 148 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code IYB — Tube Mount, X-ray, Diagnostic
Device Class Class I — General Controls
CFR Regulation 21 CFR 892.1770