Cleared Traditional

K954248 - SIEMENS VIRTURAL WEDGE

K954248 is an FDA 510(k) clearance for SIEMENS VIRTURAL WEDGE, manufactured by Siemens Medical Solutions USA, Inc.. The device is a Class 2 Radiology device with product code IXI cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K954248 · Siemens Medical Solutions USA, Inc. · Radiology device
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Jan 1996
Decision
116d
Days
Class 2
Risk

K954248 is an FDA 510(k) clearance for the SIEMENS VIRTURAL WEDGE. Classified as Block, Beam-shaping, Radiation Therapy (product code IXI), Class II - Special Controls.

Submitted by Siemens Medical Solutions USA, Inc. (Concord, US). The FDA issued a Cleared decision on January 5, 1996 after a review of 116 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5710 - 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 - K954248

510(k) Number K954248 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 1995
Decision Date January 05, 1996
Days to Decision 116 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
9d slower than avg
Panel avg: 107d · This submission: 116d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IXI Device Classification - Class 2, Special Controls

Product Code IXI Block, Beam-shaping, Radiation Therapy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5710
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 - IXI Block, Beam-shaping, Radiation Therapy

All 28
Devices cleared under the same product code (IXI) and FDA review panel - the closest regulatory comparables to K954248.
AUTIMO
K971001 · Medizintechnik, GmbH · Jun 1997
SATURNE MULTILEAF COLLIMATOR
K970303 · General Electric Co. · Apr 1997
SIEMENS BEAM SHAPER
K961902 · Siemens Medical Solutions USA, Inc. · Aug 1996
SIEMENS MULTILEAF COLLIMATOR
K953894 · Siemens Medical Solutions USA, Inc. · Nov 1995
MULTILEAF INTENSITY MODULATING COLLIMATOR
K940412 · Nomos Corp. · Feb 1995
FIELD ABUTMENT WEDGE
K943343 · Medtec, Inc. · Dec 1994