Cleared Traditional

K946053 - SIMVIEW(TM) 3000

K946053 is the FDA 510(k) clearance for SIMVIEW(TM) 3000 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 109-day FDA review.

K946053 · Siemens Medical Solutions USA, Inc. · Radiology device
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Optimized for regulatory review, auditing and printing
Mar 1995
Decision
109d
Days
Class 2
Risk

K946053 is an FDA 510(k) clearance for the SIMVIEW(TM) 3000. 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 March 31, 1995 after a review of 109 days - within the typical 510(k) review window.

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 Siemens Medical Solutions USA, Inc. devices

Submission Details

510(k) Number K946053 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 1994
Decision Date March 31, 1995
Days to Decision 109 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
2d slower than avg
Panel avg: 107d · This submission: 109d
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 K946053.
SIMVIEW 3000 CT OPTION
K953233 · Siemens Medical Solutions USA, Inc. · Nov 1996
ADVANTAGE SIM
K951830 · General Electric Co. · Nov 1995
CTPORT CT SIMULATION SYSTEM FOR RADIOTHERAPY
K945838 · Toshiba America Medical Systems, In.C · Oct 1995
ACQSIM SIMULATOR/LOCALIZER
K923851 · Philips Medical Systems (Cleveland), Inc. · Oct 1992
XIMATRON/CT OPTION
K910647 · Fischer Imaging Corp. · Sep 1991
AUTOCOMP
K911340 · Victoreen, Inc. · Aug 1991