Cleared Special

K983436 - GAMMAMED PLUS HIGH DOSE RATE REMOTE AFTERLOADING SYSTEM

K983436 is an FDA 510(k) clearance for GAMMAMED PLUS HIGH DOSE RATE REMOTE AFT..., manufactured by Gammamed USA. The device is a Class 2 Radiology device with product code JAQ cleared through the Special 510(k) pathway after a 30-day FDA review.

K983436 · Gammamed USA · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1998
Decision
30d
Days
Class 2
Risk

K983436 is an FDA 510(k) clearance for the GAMMAMED PLUS HIGH DOSE RATE REMOTE AFTERLOADING SYSTEM. Classified as System, Applicator, Radionuclide, Remote-controlled (product code JAQ), Class II - Special Controls.

Submitted by Gammamed USA (Ann Arbor, US). The FDA issued a Cleared decision on October 29, 1998 after a review of 30 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Gammamed USA devices

FDA 510(k) Submission Details - K983436

510(k) Number K983436 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 1998
Decision Date October 29, 1998
Days to Decision 30 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 107d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 158
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