Cleared Traditional

K851813 - THERPAC-RADIATION THERAPY TREATMENT PLA...

K851813 is the FDA 510(k) clearance for THERPAC-RADIATION THERAPY TREATMENT PLA... by Victoreen, Inc.. It is a Class 2 Radiology device (product code KPQ) cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K851813 · Victoreen, Inc. · Radiology device
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Aug 1985
Decision
103d
Days
Class 2
Risk

K851813 is an FDA 510(k) clearance for the THERPAC-RADIATION THERAPY TREATMENT PLANNING SYSTE. Classified as System, Simulation, Radiation Therapy (product code KPQ), Class II - Special Controls.

Submitted by Victoreen, Inc. (Carle Place, US). The FDA issued a Cleared decision on August 7, 1985 after a review of 103 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5840 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Victoreen, Inc. devices

Submission Details

510(k) Number K851813 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 1985
Decision Date August 07, 1985
Days to Decision 103 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 107d · This submission: 103d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KPQ System, Simulation, Radiation Therapy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5840
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 - KPQ System, Simulation, Radiation Therapy

All 28
Devices cleared under the same product code (KPQ) and FDA review panel - the closest regulatory comparables to K851813.
BEAMSCAN
K853671 · Victoreen, Inc. · Jan 1986
MEVAPLAN AND SOMADOS
K852410 · Siemens Medical Solutions USA, Inc. · Oct 1985
VARIAN XIMATRON C-SERIES RADIOTHERAPY TREATMENT ST
K853349 · Varian Assoc., Inc. · Oct 1985
VARIAN/XIMATRON 5 CARBON-FIBER COUCH TOP
K851653 · Varian Assoc., Inc. · May 1985
XIMATRON V
K810858 · Siemens Corp. · May 1981
SIDOS U.
K803124 · Siemens Corp. · Jan 1981