Cleared Special

K002240 - RENDER-PLAN 3-D 4.00 & PRECISE-PLAN 1.0

K002240 is an FDA 510(k) clearance for RENDER-PLAN 3-D 4.00 & PRECISE-PLAN 1.0, manufactured by Precision Therapy Intl., Inc.. The device is a Class 2 Radiology device with product code MUJ cleared through the Special 510(k) pathway after a 30-day FDA review.

K002240 · Precision Therapy Intl., Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2000
Decision
30d
Days
Class 2
Risk

K002240 is an FDA 510(k) clearance for the RENDER-PLAN 3-D 4.00 & PRECISE-PLAN 1.0. Classified as System, Planning, Radiation Therapy Treatment (product code MUJ), Class II - Special Controls.

Submitted by Precision Therapy Intl., Inc. (Norcross, US). The FDA issued a Cleared decision on August 23, 2000 after a review of 30 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. 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Precision Therapy Intl., Inc. devices

FDA 510(k) Submission Details - K002240

510(k) Number K002240 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 2000
Decision Date August 23, 2000
Days to Decision 30 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
77d faster than avg
Panel avg: 107d · This submission: 30d
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 202
Devices cleared under the same product code (MUJ) and FDA review panel - the closest regulatory comparables to K002240.
FOCUS
K002147 · Computerized Medical Systems, Inc. · Oct 2000
PEREGRINE RADIATION THERAPY DOSE CALCULATION SYSTEM
K993675 · Nomos Corp. · Sep 2000
PROTON VISION 7.0
K002312 · Varian Medical Systems, Inc. · Aug 2000
BRAINSCAN
K994413 · Brainlab AG · Jul 2000
XPLAN 2.1
K001700 · Radionics, Inc. · Jun 2000
OPTIRAD
K993895 · Permedics, Inc. · Jun 2000