Cleared Traditional

K103246 - IPLAN RT

K103246 is an FDA 510(k) clearance for IPLAN RT, manufactured by Brainlab AG. The device is a Class 2 Radiology device with product code MUJ cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K103246 · Brainlab AG · Radiology device
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Mar 2011
Decision
133d
Days
Class 2
Risk

K103246 is an FDA 510(k) clearance for the IPLAN RT. Classified as System, Planning, Radiation Therapy Treatment (product code MUJ), Class II - Special Controls.

Submitted by Brainlab AG (Feldkirchen, DE). The FDA issued a Cleared decision on March 16, 2011 after a review of 133 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5050 - 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 Brainlab AG devices

FDA 510(k) Submission Details - K103246

510(k) Number K103246 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 2010
Decision Date March 16, 2011
Days to Decision 133 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
26d slower than avg
Panel avg: 107d · This submission: 133d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MUJ Device Classification - Class 2, Special Controls

Product Code MUJ System, Planning, Radiation Therapy Treatment
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5050
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 - MUJ System, Planning, Radiation Therapy Treatment

All 208
Devices cleared under the same product code (MUJ) and FDA review panel - the closest regulatory comparables to K103246.
TOMOTHERAPY TREATMENT SYSTEM
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EQUAL DOSE
K103515 · Nucletron Corporation · Sep 2011
MONACO RTP SYSTEM
K110730 · Computerized Medical Systems, Inc. · Jun 2011
LEKSELL GAMMAPLAN
K103093 · Elekta Instrument AB · Dec 2010
XIO RTP SYSTEM
K102216 · Computerized Medical Systems, Inc. · Oct 2010
ECLIPSE TREATMENT PLANNING SYSTEM
K102011 · Varian Medical Systems, Inc. · Sep 2010