Cleared Traditional

K853671 - BEAMSCAN

K853671 is the FDA 510(k) clearance for BEAMSCAN by Victoreen, Inc.. It is a Class 2 Radiology device (product code KPQ) cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K853671 · Victoreen, Inc. · Radiology device
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Jan 1986
Decision
128d
Days
Class 2
Risk

K853671 is an FDA 510(k) clearance for the BEAMSCAN. 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 January 10, 1986 after a review of 128 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 K853671 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 1985
Decision Date January 10, 1986
Days to Decision 128 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
21d slower than avg
Panel avg: 107d · This submission: 128d
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 K853671.
GE TARGET SERIES 2
K896353 · GE Medical Systems · Dec 1989
SLS SIMULATOR (MODELS SLS-9 AND SLS-14)
K891293 · Philips Medical Systems North America, Inc. · Apr 1989
XIMAVIEW(TM)
K884323 · Varian Assoc., Inc. · Apr 1989
MEVAPLAN AND SOMADOS
K852410 · Siemens Medical Solutions USA, Inc. · Oct 1985
VARIAN XIMATRON C-SERIES RADIOTHERAPY TREATMENT ST
K853349 · Varian Assoc., Inc. · Oct 1985
THERPAC-RADIATION THERAPY TREATMENT PLANNING SYSTE
K851813 · Victoreen, Inc. · Aug 1985