Cleared Traditional

K853964 - COMPUTERIZED RADIATION TREATMENT PLANNI...

K853964 is an FDA 510(k) clearance for COMPUTERIZED RADIATION TREATMENT PLANNI..., manufactured by Computerized Medical Systems, Inc.. The device is a Class 2 Radiology device with product code LHN cleared through the Traditional 510(k) pathway after a 80-day FDA review.

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

FDA 510(k) Submission Details - K853964

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.

LHN Device Classification - Class 2, Special Controls

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 35
Devices cleared under the same product code (LHN) and FDA review panel - the closest regulatory comparables to K853964.
MODEL 37-185
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K851301 · General Electric Co. · Sep 1985