Cleared Traditional

K871810 - PLAN-32 SOFTWARE

K871810 is the FDA 510(k) clearance for PLAN-32 SOFTWARE by Oncology Systems, Inc.. It is a Class 2 Radiology device (product code JAD) cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K871810 · Oncology Systems, Inc. · Radiology device
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Oct 1987
Decision
175d
Days
Class 2
Risk

K871810 is an FDA 510(k) clearance for the PLAN-32 SOFTWARE. Classified as System, Therapeutic, X-ray (product code JAD), Class II - Special Controls.

Submitted by Oncology Systems, Inc. (Bellevue, US). The FDA issued a Cleared decision on October 30, 1987 after a review of 175 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5900 - 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 Oncology Systems, Inc. devices

Submission Details

510(k) Number K871810 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 1987
Decision Date October 30, 1987
Days to Decision 175 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
68d slower than avg
Panel avg: 107d · This submission: 175d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JAD System, Therapeutic, X-ray
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5900
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 - JAD System, Therapeutic, X-ray

All 14
Devices cleared under the same product code (JAD) and FDA review panel - the closest regulatory comparables to K871810.
VERIDOSE V (FIVE), MODEL NUMBER 37-705
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INSTA-FLO
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COMPUTERIZED TOMOGRAPHY X-RAY SYSTEM OPTION
K903377 · Siemens Medical Solutions USA, Inc. · Sep 1990
INDEPENDENT JAW MODE OPTION FOR VARIAN CLINAC 4/10
K844424 · Varian Assoc., Inc. · Feb 1985
RTP-5100-5200-5300 & 5400
K833560 · Adac Laboratories · Dec 1983
RTP-5000
K813439 · Adac Laboratories · Jan 1982