Cleared Traditional

K913425 - DIAL-A-RAD PORTA RAD TABLE (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K913425 · Dial-A-Rad · Radiology device
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Nov 1992
Decision
481d
Days
Class 2
Risk

K913425 is an FDA 510(k) clearance for the DIAL-A-RAD PORTA RAD TABLE. Classified as Table, Radiographic, Stationary Top (product code IXQ), Class II - Special Controls.

Submitted by Dial-A-Rad (Orlando, US). The FDA issued a Cleared decision on November 24, 1992 after a review of 481 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Radiology submissions.

View all Dial-A-Rad devices

Submission Details

510(k) Number K913425 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 1991
Decision Date November 24, 1992
Days to Decision 481 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
374d slower than avg
Panel avg: 107d · This submission: 481d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IXQ Table, Radiographic, Stationary Top
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.