Cleared Traditional

K894381 - GAMMAMED IRIDIUM-192 SOURCE

K894381 is an FDA 510(k) clearance for GAMMAMED IRIDIUM-192 SOURCE, manufactured by Mick Radio-Nuclear Instruments, Inc.. The device is a Class 2 Radiology device with product code JAQ cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K894381 · Mick Radio-Nuclear Instruments, Inc. · Radiology device
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Nov 1989
Decision
127d
Days
Class 2
Risk

K894381 is an FDA 510(k) clearance for the GAMMAMED IRIDIUM-192 SOURCE. Classified as System, Applicator, Radionuclide, Remote-controlled (product code JAQ), Class II - Special Controls.

Submitted by Mick Radio-Nuclear Instruments, Inc. (Bronx, US). The FDA issued a Cleared decision on November 21, 1989 after a review of 127 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 - K894381

510(k) Number K894381 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 1989
Decision Date November 21, 1989
Days to Decision 127 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
20d slower than avg
Panel avg: 107d · This submission: 127d
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 K894381.
PULSED SELECTRON
K902533 · Nucletron-Oldelft Corp. · Oct 1990
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
CURIETRON 192 HIGH DOSE RATE
K890799 · Cis-Us, Inc. · Oct 1989
GAMMAMED 12I
K891131 · Mick Radio-Nuclear Instruments, Inc. · Aug 1989
CURIETRON 192 LOW DOSE RATE
K881323 · Compagnie Oris Industrie, S.A. · Jan 1989
K894381 · GAMMAMED IRIDIUM-192 SOURCE
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