Cleared Special

K053584 - IPLAN RT DOSE (FDA 510(k) Clearance)

Class II Radiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K053584 · Brainlab AG · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2006
Decision
201d
Days
Class 2
Risk

K053584 is an FDA 510(k) clearance for the IPLAN RT DOSE. Classified as System, Planning, Radiation Therapy Treatment (product code MUJ), Class II - Special Controls.

Submitted by Brainlab AG (Heimstetten, DE). The FDA issued a Cleared decision on July 12, 2006 after a review of 201 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5050 - 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Brainlab AG devices

Submission Details

510(k) Number K053584 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2005
Decision Date July 12, 2006
Days to Decision 201 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
94d slower than avg
Panel avg: 107d · This submission: 201d
Pathway characteristics
Modification to existing cleared device.

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 251
Devices cleared under the same product code (MUJ) and FDA review panel - the closest regulatory comparables to K053584.
syngo.via RT Image Suite VC10
K252304 · Varian Medical Systems, Inc. · Mar 2026
Monaco RTP System (6.3)
K252002 · Elekta Solutions AB · Feb 2026
TrueFit Bolus
K260308 · Adaptiiv Medical Technologies, Inc. · Feb 2026
ART-Plan+ (v3.1.0)
K253091 · Therapanacea Sas · Dec 2025
RayStation (2024A SP3)
K252109 · RaySearch Laboratories AB (PUBL) · Dec 2025
ClearCalc Model RADCA V2.6
K252863 · Radformation, Inc. · Dec 2025