Cleared Traditional

K854880 - RADIATION BEAM DATA ACQUISTIOIN SYSTEMS

K854880 is an FDA 510(k) clearance for RADIATION BEAM DATA ACQUISTIOIN SYSTEMS, manufactured by Computerized Medical Systems, Inc.. The device is a Class 2 Radiology device with product code KPQ cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K854880 · Computerized Medical Systems, Inc. · Radiology device
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Jan 1986
Decision
35d
Days
Class 2
Risk

K854880 is an FDA 510(k) clearance for the RADIATION BEAM DATA ACQUISTIOIN SYSTEMS. Classified as System, Simulation, Radiation Therapy (product code KPQ), Class II - Special Controls.

Submitted by Computerized Medical Systems, Inc. (St. Louis, US). The FDA issued a Cleared decision on January 10, 1986 after a review of 35 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Computerized Medical Systems, Inc. devices

FDA 510(k) Submission Details - K854880

510(k) Number K854880 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 1985
Decision Date January 10, 1986
Days to Decision 35 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 107d · This submission: 35d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPQ Device Classification - Class 2, Special Controls

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 29
Devices cleared under the same product code (KPQ) and FDA review panel - the closest regulatory comparables to K854880.
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
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
THERPAC-RADIATION THERAPY TREATMENT PLANNING SYSTE
K851813 · Victoreen, Inc. · Aug 1985