Cleared Traditional

K894568 - NEW RAD-8 TREATMENT PLANNING COMPUTER SYSTEM

K894568 is an FDA 510(k) clearance for NEW RAD-8 TREATMENT PLANNING COMPUTER S..., manufactured by Advanced Medical Systems, Inc.. The device is a Class 2 Radiology device with product code KPQ cleared through the Traditional 510(k) pathway after a 172-day FDA review.

K894568 · Advanced Medical Systems, Inc. · Radiology device
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Jan 1990
Decision
172d
Days
Class 2
Risk

K894568 is an FDA 510(k) clearance for the NEW RAD-8 TREATMENT PLANNING COMPUTER SYSTEM. Classified as System, Simulation, Radiation Therapy (product code KPQ), Class II - Special Controls.

Submitted by Advanced Medical Systems, Inc. (Geneva, US). The FDA issued a Cleared decision on January 9, 1990 after a review of 172 days - an extended review 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: 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 Advanced Medical Systems, Inc. devices

FDA 510(k) Submission Details - K894568

510(k) Number K894568 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 1989
Decision Date January 09, 1990
Days to Decision 172 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d slower than avg
Panel avg: 107d · This submission: 172d
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 40
Devices cleared under the same product code (KPQ) and FDA review panel - the closest regulatory comparables to K894568.
MODULEX RTP SYSTEM
K913017 · Computerized Medical Systems, Inc. · Oct 1991
XIMATRON/CT OPTION
K910647 · Fischer Imaging Corp. · Sep 1991
AUTOCOMP
K911340 · Victoreen, Inc. · Aug 1991
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