Cleared Special

K013660 - GENETRA

K013660 is the FDA 510(k) clearance for GENETRA by Radiomed Corporation. It is a Class 2 Radiology device (product code KXK) cleared through the Special 510(k) pathway after a 29-day FDA review.

K013660 · Radiomed Corporation · Radiology device
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Dec 2001
Decision
29d
Days
Class 2
Risk

K013660 is an FDA 510(k) clearance for the GENETRA. Classified as Source, Brachytherapy, Radionuclide (product code KXK), Class II - Special Controls.

Submitted by Radiomed Corporation (Tyngsboro, US). The FDA issued a Cleared decision on December 5, 2001 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5730 - 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 Radiomed Corporation devices

Submission Details

510(k) Number K013660 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 2001
Decision Date December 05, 2001
Days to Decision 29 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
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
Modification to existing cleared device.

Device Classification

Product Code KXK Source, Brachytherapy, Radionuclide
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5730
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 - KXK Source, Brachytherapy, Radionuclide

All 21
Devices cleared under the same product code (KXK) and FDA review panel - the closest regulatory comparables to K013660.
SOURCELINK
K041576 · C.R. Bard, Inc. · Jul 2004
VARISEED 7.1
K030534 · Varian Medical Systems · May 2003
GAMMAMED 212 AND 232 SOURCE ASSEMBLY
K030745 · Varian Medical Systems · Mar 2003
RADIONUCLIDE CATHETERS, RNC-A, RNC-G, RNC-U
K923697 · Radionics, Inc. · Dec 1993
MANAN PROSTATE SEEDING NEEDLE
K902622 · Manan Medical Products, Inc. · Aug 1990
3M I-125 SEEDS IN ABSORBABLE CARRIER
K801748 · 3M Company · Dec 1980