Cleared Traditional

K102811 - AOS ORION IR-192 SOURCE CABLE

K102811 is an FDA 510(k) clearance for AOS ORION IR-192 SOURCE CABLE, manufactured by Alpha-Omega Services, Inc.. The device is a Class 2 Radiology device with product code KXK cleared through the Traditional 510(k) pathway after a 247-day FDA review.

K102811 · Alpha-Omega Services, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2011
Decision
247d
Days
Class 2
Risk

K102811 is an FDA 510(k) clearance for the AOS ORION IR-192 SOURCE CABLE. Classified as Source, Brachytherapy, Radionuclide (product code KXK), Class II - Special Controls.

Submitted by Alpha-Omega Services, Inc. (Bellflower, US). The FDA issued a Cleared decision on June 2, 2011 after a review of 247 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5730 - 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.

View all Alpha-Omega Services, Inc. devices

FDA 510(k) Submission Details - K102811

510(k) Number K102811 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2010
Decision Date June 02, 2011
Days to Decision 247 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
140d slower than avg
Panel avg: 107d · This submission: 247d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KXK Device Classification - Class 2, Special Controls

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 136
Devices cleared under the same product code (KXK) and FDA review panel - the closest regulatory comparables to K102811.
PRE-LOADED GOLD VISICOIL CK MARKER
K120859 · Radiomed Corporation · Apr 2012
RADIOACTIVE SEED LOCALIZATION NEEDLE
K111979 · Biocompatibles, Inc. · Oct 2011
GLIASITE RTS
K111931 · Isoray Medical, Inc. · Aug 2011
BRACHYTHERAPY NEEDLES, RP SLEEVE, RP BRACHY-SPACER, GOLD MAKERS
K103449 · Riverpoint Medical · Feb 2011
I-SEED
K103319 · Theragenics Corp. · Jan 2011
SYNTHETIC SEEDING SPACER MODEL SS9 X 50-50, SS9 X 55-50, SS9 X 55-150, SS9 X 1CM-30
K100847 · Biocompatibles, Inc. · May 2010