Cleared Abbreviated

K073373 - SYNGO VOLUME PERFUSION-CT BODY

K073373 is the FDA 510(k) clearance for SYNGO VOLUME PERFUSION-CT BODY by Siemens AG Medical Solutions. It is a Class 2 Radiology device (product code JAK) cleared through the Abbreviated 510(k) pathway after a 15-day FDA review.

K073373 · Siemens AG Medical Solutions · Radiology device
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Dec 2007
Decision
15d
Days
Class 2
Risk

K073373 is an FDA 510(k) clearance for the SYNGO VOLUME PERFUSION-CT BODY. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Siemens AG Medical Solutions (Erlangen, DE). The FDA issued a Cleared decision on December 18, 2007 after a review of 15 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 AG Medical Solutions devices

Submission Details

510(k) Number K073373 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 2007
Decision Date December 18, 2007
Days to Decision 15 days
Submission Type Abbreviated
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 107d · This submission: 15d
Pathway characteristics
Standards-based clearance path. Third-party reviewed.

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 Consultant

Tuv Sud America, Inc.
STEPHEN PREISS

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - JAK System, X-ray, Tomography, Computed

All 607
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K073373.
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