Cleared Traditional

K011816 - MINI MULTILEAF COLLIMATOR, MODEL KMI

K011816 is an FDA 510(k) clearance for MINI MULTILEAF COLLIMATOR, manufactured by Mrc Systems GmbH. The device is a Class 2 Radiology device with product code IXI cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K011816 · Mrc Systems GmbH · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2001
Decision
88d
Days
Class 2
Risk

K011816 is an FDA 510(k) clearance for the MINI MULTILEAF COLLIMATOR, MODEL KMI. 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 September 7, 2001 after a review of 88 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K011816

510(k) Number K011816 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 2001
Decision Date September 07, 2001
Days to Decision 88 days
Submission Type Traditional
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
19d faster than avg
Panel avg: 107d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K011816.
MODULEAF
K030609 · Mrc Systems GmbH · Mar 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
LEAD BLOCKS
K010172 · Arplay Medical S.A. · Apr 2001
DMLC IV-ERGO
K001163 · 3D Line USA, Inc. · Oct 2000
MOTORIZED MICRO MULTILEAF COLLIMATOR
K000349 · Stryker Leibinger · May 2000
K011816 · MINI MULTILEAF COLLIMATOR, MODEL KMI
Download PDF FDA Summary Mrc Systems GmbH