Cleared Traditional

K902533 - PULSED SELECTRON

K902533 is an FDA 510(k) clearance for PULSED SELECTRON, manufactured by Nucletron-Oldelft Corp.. The device is a Class 2 Radiology device with product code JAQ cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K902533 · Nucletron-Oldelft Corp. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1990
Decision
126d
Days
Class 2
Risk

K902533 is an FDA 510(k) clearance for the PULSED SELECTRON. Classified as System, Applicator, Radionuclide, Remote-controlled (product code JAQ), Class II - Special Controls.

Submitted by Nucletron-Oldelft Corp. (Columbia, US). The FDA issued a Cleared decision on October 12, 1990 after a review of 126 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5700 - 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.

FDA 510(k) Submission Details - K902533

510(k) Number K902533 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 1990
Decision Date October 12, 1990
Days to Decision 126 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
19d slower than avg
Panel avg: 107d · This submission: 126d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JAQ Device Classification - Class 2, Special Controls

Product Code JAQ System, Applicator, Radionuclide, Remote-controlled
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5700
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 - JAQ System, Applicator, Radionuclide, Remote-controlled

All 207
Devices cleared under the same product code (JAQ) and FDA review panel - the closest regulatory comparables to K902533.
OMNITRON GYN APPLICATOR SYSTEM
K913908 · Omnitron Intl., Inc. · Mar 1992
RTS TECHNOLOGY MODELS 721,722,723,724
K914578 · Rts Technology, Inc. · Feb 1992
GAMMAMED 12IT HIGH DOSE RATE REMOTE AFTERLOADER
K912555 · Rts Technology, Inc. · Aug 1991
RTS TECHNOLOGY IRIDIUM 192 SOURCES
K901589 · Rts Technology, Inc. · Aug 1990
INTER-PAL C-19 AND INTER-PAL C-38
K890294 · Enrad Corp. · Feb 1990
GAMMAMED IRIDIUM-192 SOURCE
K894381 · Mick Radio-Nuclear Instruments, Inc. · Nov 1989
K902533 · PULSED SELECTRON
Download PDF Nucletron-Oldelft Cor…