Cleared Traditional

K052220 - IPLAN RT FIBERTRACKING

K052220 is the FDA 510(k) clearance for IPLAN RT FIBERTRACKING by Brainlab AG. It is a Class 2 Radiology device (product code IYE) cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K052220 · Brainlab AG · Radiology device
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Sep 2005
Decision
46d
Days
Class 2
Risk

K052220 is an FDA 510(k) clearance for the IPLAN RT FIBERTRACKING. Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by Brainlab AG (Heimstetten, DE). The FDA issued a Cleared decision on September 30, 2005 after a review of 46 days - a notably fast clearance cycle.

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

View all Brainlab AG devices

Submission Details

510(k) Number K052220 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 2005
Decision Date September 30, 2005
Days to Decision 46 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
61d faster than avg
Panel avg: 107d · This submission: 46d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IYE Accelerator, Linear, Medical
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 - IYE Accelerator, Linear, Medical

All 315
Devices cleared under the same product code (IYE) and FDA review panel - the closest regulatory comparables to K052220.
ONCOR EXPRESSION
K060226 · Siemens Medical Solutions USA, Inc. · Mar 2006
FRAMELESS RADIOSURGERY COMPONENTS
K053500 · Brainlab AG · Feb 2006
VISION (WITH OFF-LINE REVIEW)
K052391 · Varian Medical Systems · Nov 2005
4D INTEGRATED TREATMENT CONSOLE
K050479 · Varian Medical Systems · Mar 2005
MILLENNIUM MULTI-LEAF COLLIMATOR
K050442 · Varian Medical Systems · Mar 2005
VISION
K042956 · Varian Medical Systems, Inc. · Mar 2005