Cleared Traditional

K955484 - XENON OPTION TO PRISM 3000

K955484 is the FDA 510(k) clearance for XENON OPTION TO PRISM 3000 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 119-day FDA review.

K955484 · Philips Medical Systems (Cleveland), Inc. · Radiology device
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Mar 1996
Decision
119d
Days
Class 2
Risk

K955484 is an FDA 510(k) clearance for the XENON OPTION TO PRISM 3000. 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 March 29, 1996 after a review of 119 days - within the typical 510(k) review window.

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 K955484 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 1995
Decision Date March 29, 1996
Days to Decision 119 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
12d slower than avg
Panel avg: 107d · This submission: 119d
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 K955484.
STEP OPTION TO PRISM 2000
K960865 · Philips Medical Systems (Cleveland), Inc. · Sep 1996
POSITRON COINCIDENCE DETECTION
K960192 · Philips Medical Systems (Cleveland), Inc. · Sep 1996
PRISM 3000XPV SYSTEM (210714)
K961577 · Philips Medical Systems (Cleveland), Inc. · Jul 1996
SPECTEF PROTOCOL
K954874 · GE Medical Systems · Feb 1996
VERTEX EPIC MCD
K952684 · Adac Laboratories · Nov 1995
INSPECT/PROSPECT
K952564 · Adac Laboratories · Nov 1995