Cleared Traditional

K962613 - DARPAC 2000 SUPERFICIAL X-RAY THERAPY SYSTEM (FDA 510(k) Clearance)

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

K962613 · Gulmay Medical , Ltd. · Radiology device
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Sep 1996
Decision
86d
Days
Class 2
Risk

K962613 is an FDA 510(k) clearance for the DARPAC 2000 SUPERFICIAL X-RAY THERAPY SYSTEM. Classified as System, Therapeutic, X-ray (product code JAD), Class II - Special Controls.

Submitted by Gulmay Medical , Ltd. (Shepperton, Middlesex, GB). The FDA issued a Cleared decision on September 27, 1996 after a review of 86 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5900 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Gulmay Medical , Ltd. devices

Submission Details

510(k) Number K962613 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 1996
Decision Date September 27, 1996
Days to Decision 86 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
21d faster than avg
Panel avg: 107d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JAD System, Therapeutic, X-ray
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5900
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.