Cleared Abbreviated

K032536 - SOMATOM EXTENDED FIELD OF VIEW SOFTWARE...

K032536 is the FDA 510(k) clearance for SOMATOM EXTENDED FIELD OF VIEW SOFTWARE... by Siemens Medical Solutions USA, Inc.. It is a Class 2 Radiology device (product code JAK) cleared through the Abbreviated 510(k) pathway after a 84-day FDA review.

K032536 · Siemens Medical Solutions USA, Inc. · Radiology device
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Nov 2003
Decision
84d
Days
Class 2
Risk

K032536 is an FDA 510(k) clearance for the SOMATOM EXTENDED FIELD OF VIEW SOFTWARE OPTION. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Siemens Medical Solutions USA, Inc. (Mavern, US). The FDA issued a Cleared decision on November 10, 2003 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1750 - the FDA radiology and imaging software oversight framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Siemens Medical Solutions USA, Inc. devices

Submission Details

510(k) Number K032536 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 2003
Decision Date November 10, 2003
Days to Decision 84 days
Submission Type Abbreviated
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
23d faster than avg
Panel avg: 107d · This submission: 84d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code JAK System, X-ray, Tomography, Computed
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1750
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 - JAK System, X-ray, Tomography, Computed

All 581
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K032536.
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SOMATON COMPUTED TOMOGRAPHY X-RAY SYSTEMS SLIDING GANTRY OPTION
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K033418 · Toshiba America Medical Systems, In.C · Nov 2003
ADVANTAGE 4D OPTION
K032915 · Ge Medical Systems, LLC · Oct 2003
PHILIPS PLUS COMPUTED TOMOGRAPHY SYSTEM
K033326 · Philips Medical Systems, Inc. · Oct 2003