Cleared Traditional

COMPUTERIZED RADIATION TREATMENT PLANNING SYS (K853964) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K853964 · Computerized Medical Systems, Inc. · Radiology device
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Dec 1985
Decision
80d
Days
Class 2
Risk

K853964 is an FDA 510(k) clearance for the COMPUTERIZED RADIATION TREATMENT PLANNING SYS. Classified as System, Radiation Therapy, Charged-particle, Medical (product code LHN), Class II - Special Controls.

Submitted by Computerized Medical Systems, Inc. (St. Louis, US). The FDA issued a Cleared decision on December 5, 1985 after a review of 80 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. 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

Submission Details

510(k) Number K853964 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 1985
Decision Date December 05, 1985
Days to Decision 80 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 107d · This submission: 80d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LHN System, Radiation Therapy, Charged-particle, Medical
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 - LHN System, Radiation Therapy, Charged-particle, Medical

All 27
Devices cleared under the same product code (LHN) and FDA review panel - the closest regulatory comparables to K853964.
RADIO-PLAST
K981115 · Smith & Nephew, Inc. · Jun 1998
TREATMENT MANAGEMENT SYSTEM
K953391 · Siemens Medical Solutions USA, Inc. · Mar 1996
INTRAOPERATIVE RADIATION THERAPY DEVICES
K891261 · General Electric Co. · Apr 1989
TARGET CAT#B7850AA & B7850AB & B7850B
K851301 · General Electric Co. · Sep 1985