Cleared Traditional

K960865 - STEP OPTION TO PRISM 2000

K960865 is the FDA 510(k) clearance for STEP OPTION TO PRISM 2000 by Philips Medical Systems (Cleveland), Inc.. It is a Class 2 Radiology device (product code KPS) cleared through the Traditional 510(k) pathway after a 200-day FDA review.

K960865 · Philips Medical Systems (Cleveland), Inc. · Radiology device
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Sep 1996
Decision
200d
Days
Class 2
Risk

K960865 is an FDA 510(k) clearance for the STEP OPTION TO PRISM 2000. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Philips Medical Systems (Cleveland), Inc. (Cleveland, US). The FDA issued a Cleared decision on September 20, 1996 after a review of 200 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1200 - 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 Philips Medical Systems (Cleveland), Inc. devices

Submission Details

510(k) Number K960865 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 1996
Decision Date September 20, 1996
Days to Decision 200 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
93d slower than avg
Panel avg: 107d · This submission: 200d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KPS System, Tomography, Computed, Emission
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1200
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 - KPS System, Tomography, Computed, Emission

All 242
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K960865.
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XENON OPTION TO PRISM 3000
K955484 · Philips Medical Systems (Cleveland), Inc. · Mar 1996