Cleared Special

K072445 - INTEGRATED BRACHYTHERAPY UNIT - DIGITAL

K072445 is an FDA 510(k) clearance for INTEGRATED BRACHYTHERAPY UNIT - DIGITAL, manufactured by Nucletron Corp.. The device is a Class 2 Radiology device with product code KPQ cleared through the Special 510(k) pathway after a 15-day FDA review.

K072445 · Nucletron Corp. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2007
Decision
15d
Days
Class 2
Risk

K072445 is an FDA 510(k) clearance for the INTEGRATED BRACHYTHERAPY UNIT - DIGITAL. Classified as System, Simulation, Radiation Therapy (product code KPQ), Class II - Special Controls.

Submitted by Nucletron Corp. (Columbia, US). The FDA issued a Cleared decision on September 14, 2007 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5840 - 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 Nucletron Corp. devices

FDA 510(k) Submission Details - K072445

510(k) Number K072445 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 2007
Decision Date September 14, 2007
Days to Decision 15 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
92d faster than avg
Panel avg: 107d · This submission: 15d
Pathway characteristics
Modification to existing cleared device.

KPQ Device Classification - Class 2, Special Controls

Product Code KPQ System, Simulation, Radiation Therapy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5840
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 - KPQ System, Simulation, Radiation Therapy

All 42
Devices cleared under the same product code (KPQ) and FDA review panel - the closest regulatory comparables to K072445.
RAD II SIMULATOR, RAD II KV IMAGER, DUAL RAD II KV IMAGER
K101038 · Acceletronics Digital Imaging, LLC · Aug 2010
ONCENTRA SIMULATION 2.3
K090706 · Nucletron Corporation · Jun 2009
IKOENGELO, VERSION 2
K083591 · Ikoetech, LLC · Dec 2008
IKOENGELO
K061006 · Ikoetech, LLC · Jun 2006
SIMULIX-EVOLUTION WITH ONCENTRA CONEBEAM
K052361 · Nucletron Corporation · Oct 2005
ADVANTAGE SIM MD
K052345 · Ge Healthcare · Sep 2005