Cleared Traditional

K022036 - SIEMENS VIRTUAL SIMULATION (VSIM)

K022036 is an FDA 510(k) clearance for SIEMENS VIRTUAL SIMULATION (VSIM), manufactured by Siemens Medical Solutions USA, Inc.. The device is a Class 2 Radiology device with product code MUJ cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K022036 · Siemens Medical Solutions USA, Inc. · Radiology device
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Nov 2002
Decision
134d
Days
Class 2
Risk

K022036 is an FDA 510(k) clearance for the SIEMENS VIRTUAL SIMULATION (VSIM). Classified as System, Planning, Radiation Therapy Treatment (product code MUJ), Class II - Special Controls.

Submitted by Siemens Medical Solutions USA, Inc. (San Diego, US). The FDA issued a Cleared decision on November 5, 2002 after a review of 134 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5050 - 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

FDA 510(k) Submission Details - K022036

510(k) Number K022036 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 2002
Decision Date November 05, 2002
Days to Decision 134 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
27d slower than avg
Panel avg: 107d · This submission: 134d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MUJ Device Classification - Class 2, Special Controls

Product Code MUJ System, Planning, Radiation Therapy Treatment
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5050
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 - MUJ System, Planning, Radiation Therapy Treatment

All 208
Devices cleared under the same product code (MUJ) and FDA review panel - the closest regulatory comparables to K022036.
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ACQPLAN 5.0
K013644 · Philips Medical Systems, Inc. · Sep 2002