Cleared Traditional

K943926 - RAPIDO 2000 AUTOMATIC RADIOGRAPHIC TABLE (FDA 510(k) Clearance)

Nov 1994
Decision
108d
Days
Class 2
Risk

K943926 is an FDA 510(k) clearance for the RAPIDO 2000 AUTOMATIC RADIOGRAPHIC TABLE. This device is classified as a Table, Radiographic, Non-tilting, Powered (Class II - Special Controls, product code IZZ).

Submitted by Philips Medical Systems (Cleveland), Inc. (Cleveland, US). The FDA issued a Cleared decision on November 28, 1994, 108 days after receiving the submission on August 12, 1994.

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

Submission Details

510(k) Number K943926 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1994
Decision Date November 28, 1994
Days to Decision 108 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

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