Cleared Traditional

K033832 - SYNGO PERFUSION-CT

K033832 is the FDA 510(k) clearance for SYNGO PERFUSION-CT by Siemens AG Medical Solutions. It is a Class 2 Radiology device (product code JAK) cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K033832 · Siemens AG Medical Solutions · Radiology device
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Dec 2003
Decision
13d
Days
Class 2
Risk

K033832 is an FDA 510(k) clearance for the SYNGO PERFUSION-CT. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Siemens AG Medical Solutions (Forchheim, DE). The FDA issued a Cleared decision on December 23, 2003 after a review of 13 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Siemens AG Medical Solutions devices

Submission Details

510(k) Number K033832 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 2003
Decision Date December 23, 2003
Days to Decision 13 days
Submission Type Traditional
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
94d faster than avg
Panel avg: 107d · This submission: 13d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. 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 America, Inc.
STEFAN 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 604
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K033832.
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K033677 · Philips Medical Systems (Cleveland), Inc. · Feb 2004
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K033357 · Philips Medical Systems (Cleveland), Inc. · Jan 2004
LIGHTSPEED 6.0 CT SCANNER SYSTEM
K033502 · Ge Medical Systems, LLC · Nov 2003
SOMATON COMPUTED TOMOGRAPHY X-RAY SYSTEMS SLIDING GANTRY OPTION
K032475 · Siemens Medical Solutions USA, Inc. · Nov 2003
SOMATOM EXTENDED FIELD OF VIEW SOFTWARE OPTION
K032536 · Siemens Medical Solutions USA, Inc. · Nov 2003