Cleared Special

K030609 - MODULEAF

K030609 is an FDA 510(k) clearance for MODULEAF, manufactured by Mrc Systems GmbH. The device is a Class 2 Radiology device with product code IXI cleared through the Special 510(k) pathway after a 19-day FDA review.

K030609 · Mrc Systems GmbH · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2003
Decision
19d
Days
Class 2
Risk

K030609 is an FDA 510(k) clearance for the MODULEAF. Classified as Block, Beam-shaping, Radiation Therapy (product code IXI), Class II - Special Controls.

Submitted by Mrc Systems GmbH (Heidelberg, DE). The FDA issued a Cleared decision on March 17, 2003 after a review of 19 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5710 - 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 - K030609

510(k) Number K030609 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 2003
Decision Date March 17, 2003
Days to Decision 19 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
88d faster than avg
Panel avg: 107d · This submission: 19d
Pathway characteristics
Modification to existing cleared device.

IXI Device Classification - Class 2, Special Controls

Product Code IXI Block, Beam-shaping, Radiation Therapy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5710
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 - IXI Block, Beam-shaping, Radiation Therapy

All 49
Devices cleared under the same product code (IXI) and FDA review panel - the closest regulatory comparables to K030609.
.DECIMAL TISSUE COMPENSATOR/INTENSITY MODULATOR
K040804 · Southeastern Radiation Products, Inc. · Apr 2004
MODIFICATION TO ACCULEAF
K040553 · Direx Systems Corp. · Apr 2004
MICROMLC
K032790 · Siemens Medical Solutions USA, Inc. · Oct 2003
PARCOMPLAST COMPENSATING FILTER FOR RADIATION THERAPY
K021987 · S&S Par Scientific · Dec 2002
MED-TEC COMPENSATOR BLOCK CUTTER SOFTWARE
K013875 · Med-Tec,Inc. · Sep 2002
MINI MULTILEAF COLLIMATOR, MODEL KMI
K011816 · Mrc Systems GmbH · Sep 2001
K030609 · MODULEAF
Download PDF FDA Summary Mrc Systems GmbH