Cleared Traditional

K923584 - THERAPAX DXT 300 SERIES 3

K923584 is an FDA 510(k) clearance for THERAPAX DXT 300 SERIES 3, manufactured by Oldelft Corp. of America. The device is a Class 2 Radiology device with product code JAD cleared through the Traditional 510(k) pathway after a 179-day FDA review.

K923584 · Oldelft Corp. of America · Radiology device
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Jan 1993
Decision
179d
Days
Class 2
Risk

K923584 is an FDA 510(k) clearance for the THERAPAX DXT 300 SERIES 3. Classified as System, Therapeutic, X-ray (product code JAD), Class II - Special Controls.

Submitted by Oldelft Corp. of America (Fairfax, US). The FDA issued a Cleared decision on January 15, 1993 after a review of 179 days - an extended review 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: 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 Oldelft Corp. of America devices

FDA 510(k) Submission Details - K923584

510(k) Number K923584 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 1992
Decision Date January 15, 1993
Days to Decision 179 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
72d slower than avg
Panel avg: 107d · This submission: 179d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JAD Device Classification - Class 2, Special Controls

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.

Regulatory Peers - JAD System, Therapeutic, X-ray

All 20
Devices cleared under the same product code (JAD) and FDA review panel - the closest regulatory comparables to K923584.
PHOTON RADIOSURGERY SYSTEM (PRS)
K964947 · Photoelectron Corporation · Jun 1997
THERAPAX SXT 150
K971074 · Pantak, Inc. · Jun 1997
INSTA-FLO
K935209 · Medtec, Inc. · Dec 1993
COMPUTERIZED TOMOGRAPHY X-RAY SYSTEM OPTION
K903377 · Siemens Medical Solutions USA, Inc. · Sep 1990
CMS RECORD AND VERIFY SYSTEM
K882484 · Computerized Medical Systems, Inc. · Dec 1988
INDEPENDENT JAW MODE OPTION FOR VARIAN CLINAC 4/10
K844424 · Varian Assoc., Inc. · Feb 1985