Cleared Traditional

K103246 - IPLAN RT

K103246 is the FDA 510(k) clearance for IPLAN RT by Brainlab AG. It is a Class 2 Radiology device (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

Submission Details

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.

Device Classification

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 130
Devices cleared under the same product code (MUJ) and FDA review panel - the closest regulatory comparables to K103246.
4D INTEGRATED TREATMENT CONSOLE
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ECLIPSE TREATMENT PLANNING SYSTEM
K131891 · Varian Medical Systems, Inc. · Sep 2013
SYNGO RT INTERFACE
K120363 · Siemens Medical Solutions USA, Inc. · Mar 2012
LEKSELL GAMMAPLAN
K103093 · Elekta Instrument AB · Dec 2010
ECLIPSE TREATMENT PLANNING SYSTEM
K102011 · Varian Medical Systems, Inc. · Sep 2010
SYNGO DOSIMETRIST WORKSPACE V2.7 MODEL: 1056864
K101119 · Siemens Medical Solutions USA, Inc. · Jun 2010