Cleared Traditional

K954248 - SIEMENS VIRTURAL WEDGE

K954248 is the FDA 510(k) clearance for SIEMENS VIRTURAL WEDGE by Siemens Medical Solutions USA, Inc.. It is a Class 2 Radiology device (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

Submission Details

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.

Device Classification

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 12
Devices cleared under the same product code (IXI) and FDA review panel - the closest regulatory comparables to K954248.
ANGIO-CT MIYABI
K990491 · Siemens Medical Solutions USA, Inc. · Apr 1999
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
FIELD ABUTMENT WEDGE
K943343 · Medtec, Inc. · Dec 1994
360 DEG. ROTATING 1/2 BEAM BLOCK
K941719 · Medtec, Inc. · Jul 1994