Cleared Special

K053584 - IPLAN RT DOSE

K053584 is an FDA 510(k) clearance for IPLAN RT DOSE, manufactured by Brainlab AG. The device is a Class 2 Radiology device with product code MUJ cleared through the Special 510(k) pathway after a 201-day FDA review.

K053584 · Brainlab AG · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K053584

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
94d slower than avg
Panel avg: 107d · This submission: 201d
Pathway characteristics
Modification to existing cleared device.

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 257
Devices cleared under the same product code (MUJ) and FDA review panel - the closest regulatory comparables to K053584.
ACCUSOFT, ACCUSOFT XL
K062032 · Direx Systems Corp. · Oct 2006
CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM
K062514 · Accuray Incorporated · Sep 2006
INTEGRA RADIONICS XKNIFE RT 4
K061893 · Integra Radionics, Inc. · Jul 2006
P.D
K061440 · .Decimal, Inc. · Jun 2006
COHERENCE DOSIMETRIST, MODEL 2.2
K061097 · Siemens Medical Solutions USA, Inc. · Jun 2006
ECLIPSE TREATMENT PLANNING SYSTEM
K050296 · Varian Medical Systems · Nov 2005
K053584 · IPLAN RT DOSE
Download PDF FDA Summary Brainlab AG