Cleared Special

K992864 - RENDER-PLAN 3-D

K992864 is an FDA 510(k) clearance for RENDER-PLAN 3-D, 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 15-day FDA review.

K992864 · Precision Therapy Intl., Inc. · Radiology device
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Sep 1999
Decision
15d
Days
Class 2
Risk

K992864 is an FDA 510(k) clearance for the RENDER-PLAN 3-D. 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 September 9, 1999 after a review of 15 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 - K992864

510(k) Number K992864 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 1999
Decision Date September 09, 1999
Days to Decision 15 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
92d faster than avg
Panel avg: 107d · This submission: 15d
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 201
Devices cleared under the same product code (MUJ) and FDA review panel - the closest regulatory comparables to K992864.
ITP, MODEL 1.0
K992434 · Nucletron Corp. · Jan 2000
HELAX-TMS V 5.0 RADIATION THERAPY TREATMENT PLANNING SYSTEM
K993766 · Helax AB · Dec 1999
TRAPIS (TRANSPERINEAL PROSTATE IMPLANT SIMULATOR), VERSION 1.5
K990475 · Kps & Assoc., Inc. · Nov 1999
CADPLAN PLUS: 3D TREATMENT PLANNING SYSTEM
K992753 · Varian Assoc., Inc. · Sep 1999
XPLAN-2 WITH HEAD AND NECK LOCALIZER, MODEL HNL
K991237 · Radionics, Inc. · Aug 1999
EXPLORER 3D
K991815 · Our Scientific Intl., Inc. · Aug 1999