Cleared Special

K070468 - IMPLANT SCIENCES CORP. MODEL HDR 4454

K070468 is an FDA 510(k) clearance for IMPLANT SCIENCES CORP. MODEL HDR 4454, manufactured by Implant Sciences Corp.. The device is a Class 2 Radiology device with product code KXK cleared through the Special 510(k) pathway after a 35-day FDA review.

K070468 · Implant Sciences Corp. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2007
Decision
35d
Days
Class 2
Risk

K070468 is an FDA 510(k) clearance for the IMPLANT SCIENCES CORP. MODEL HDR 4454. Classified as Source, Brachytherapy, Radionuclide (product code KXK), Class II - Special Controls.

Submitted by Implant Sciences Corp. (Wakefield, US). The FDA issued a Cleared decision on March 23, 2007 after a review of 35 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.

FDA 510(k) Submission Details - K070468

510(k) Number K070468 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 2007
Decision Date March 23, 2007
Days to Decision 35 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
72d faster than avg
Panel avg: 107d · This submission: 35d
Pathway characteristics
Modification to existing cleared device.

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 150
Devices cleared under the same product code (KXK) and FDA review panel - the closest regulatory comparables to K070468.
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BRACHYSCIENCES STRANDPORT
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RAPID STRAND RX
K063177 · Oncura, Inc. · Nov 2006
CESIUM-131 STRAND, STRAND PRELOAD, PRELOAD, S-CARTRIDGE
K062384 · Isoray, Inc. · Nov 2006
K070468 · IMPLANT SCIENCES CORP. MODEL HDR 4454
Download PDF FDA Summary Implant Sciences Corp.