Cleared Traditional

K943926 - RAPIDO 2000 AUTOMATIC RADIOGRAPHIC TABLE

K943926 is the FDA 510(k) clearance for RAPIDO 2000 AUTOMATIC RADIOGRAPHIC TABLE by Philips Medical Systems (Cleveland), Inc.. It is a Class 2 Radiology device (product code IZZ) cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K943926 · Philips Medical Systems (Cleveland), Inc. · Radiology device
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Nov 1994
Decision
108d
Days
Class 2
Risk

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

Submitted by Philips Medical Systems (Cleveland), Inc. (Cleveland, US). The FDA issued a Cleared decision on November 28, 1994 after a review of 108 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1980 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Philips Medical Systems (Cleveland), Inc. devices

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
1d slower than avg
Panel avg: 107d · This submission: 108d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IZZ Table, Radiographic, Non-tilting, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1980
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - IZZ Table, Radiographic, Non-tilting, Powered

All 12
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