Cleared Traditional

K953233 - SIMVIEW 3000 CT OPTION

K953233 is the FDA 510(k) clearance for SIMVIEW 3000 CT OPTION by Siemens Medical Solutions USA, Inc.. It is a Class 2 Radiology device (product code KPQ) cleared through the Traditional 510(k) pathway after a 508-day FDA review.

K953233 · Siemens Medical Solutions USA, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1996
Decision
508d
Days
Class 2
Risk

K953233 is an FDA 510(k) clearance for the SIMVIEW 3000 CT OPTION. Classified as System, Simulation, Radiation Therapy (product code KPQ), Class II - Special Controls.

Submitted by Siemens Medical Solutions USA, Inc. (Concord, US). The FDA issued a Cleared decision on November 29, 1996 after a review of 508 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Radiology submissions.

View all Siemens Medical Solutions USA, Inc. devices

Submission Details

510(k) Number K953233 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 1995
Decision Date November 29, 1996
Days to Decision 508 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
401d slower than avg
Panel avg: 107d · This submission: 508d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 26
Devices cleared under the same product code (KPQ) and FDA review panel - the closest regulatory comparables to K953233.
SOMAVISION
K992751 · Varian Assoc., Inc. · Feb 2000
VARIAN RADIATION THERAPY IMAGING SYSTEM
K971839 · Varian Medical Systems, Inc. · Aug 1997
VARIAN XIMATRON C-SERIES RADIATION THERAPY SIMULATOR WITH VERSION 4.2 SOFTWARE
K964138 · Varian Medical Systems, Inc. · Jan 1997
ADVANTAGE SIM
K951830 · General Electric Co. · Nov 1995
CTPORT CT SIMULATION SYSTEM FOR RADIOTHERAPY
K945838 · Toshiba America Medical Systems, In.C · Oct 1995
SIMVIEW(TM) 3000
K946053 · Siemens Medical Solutions USA, Inc. · Mar 1995