Cleared Traditional

EURO, SCST, SCCFT ATLAS RADIOLOGIC TABLES

K946262 · Scott Imaging Intl., Inc. · Radiology
Feb 1995
Decision
64d
Days
Class 2
Risk

About This 510(k) Submission

K946262 is an FDA 510(k) clearance for the EURO, SCST, SCCFT ATLAS RADIOLOGIC TABLES, a Table, Radiographic, Stationary Top (Class II — Special Controls, product code IXQ), submitted by Scott Imaging Intl., Inc. (Mobile, US). The FDA issued a Cleared decision on February 15, 1995, 64 days after receiving the submission on December 13, 1994. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1980.

Submission Details

510(k) Number K946262 FDA.gov
FDA Decision Cleared SESE
Date Received December 13, 1994
Decision Date February 15, 1995
Days to Decision 64 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement

Device Classification

Product Code IXQ — Table, Radiographic, Stationary Top
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1980

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