Cleared Traditional

K924444 - B-4 FOUR-WAY RADIOGRAPHIC TABLE
(FDA 510(k) Clearance)

Feb 1993
Decision
157d
Days
Class 2
Risk

K924444 is an FDA 510(k) clearance for the B-4 FOUR-WAY RADIOGRAPHIC TABLE. This device is classified as a Table, Radiographic, Non-tilting, Powered (Class II - Special Controls, product code IZZ).

Submitted by Control-X, Inc. (Columbus, US). The FDA issued a Cleared decision on February 5, 1993, 157 days after receiving the submission on September 1, 1992.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1980.

Submission Details

510(k) Number K924444 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 1992
Decision Date February 05, 1993
Days to Decision 157 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement

Device Classification

Product Code IZZ — Table, Radiographic, Non-tilting, Powered
Device Class Class II - Special Controls
CFR Regulation 21 CFR 892.1980

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