Cleared Traditional

K864210 - MICROSELECTRON-HDR (HIGH DOSE RATE)

K864210 is an FDA 510(k) clearance for MICROSELECTRON-HDR (HIGH DOSE RATE), 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 29-day FDA review.

K864210 · Nucletron-Oldelft Corp. · Radiology device
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Nov 1986
Decision
29d
Days
Class 2
Risk

K864210 is an FDA 510(k) clearance for the MICROSELECTRON-HDR (HIGH DOSE RATE). 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 November 26, 1986 after a review of 29 days - a notably fast clearance cycle.

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: 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 Nucletron-Oldelft Corp. devices

FDA 510(k) Submission Details - K864210

510(k) Number K864210 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1986
Decision Date November 26, 1986
Days to Decision 29 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 107d · This submission: 29d
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 159
Devices cleared under the same product code (JAQ) and FDA review panel - the closest regulatory comparables to K864210.
HIGH DOSE RATE REMOTE AFTERLOADING CATHETER
K923738 · Cook, Inc. · Apr 1993
GAMMAMED IRIDIUM-192 SOURCE
K894381 · Mick Radio-Nuclear Instruments, Inc. · Nov 1989
GAMMAMED 12I
K891131 · Mick Radio-Nuclear Instruments, Inc. · Aug 1989
CURIETRON
K840127 · Syncor Intl. Corp. · Mar 1984
MULTITREAT 48
K834308 · Mick Radio-Nuclear Instruments, Inc. · Jan 1984
SELECTRON REMOTE ISOTOPE
K810051 · Victoreen, Inc. · Feb 1981