Cleared Traditional

K073238 - SYNGO VOLUME PERFUSION-CT NEURO

K073238 is the FDA 510(k) clearance for SYNGO VOLUME PERFUSION-CT NEURO by Siemens AG Medical Solutions. It is a Class 2 Radiology device (product code JAK) cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K073238 · Siemens AG Medical Solutions · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2008
Decision
48d
Days
Class 2
Risk

K073238 is an FDA 510(k) clearance for the SYNGO VOLUME PERFUSION-CT NEURO. 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 January 3, 2008 after a review of 48 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 K073238 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 2007
Decision Date January 03, 2008
Days to Decision 48 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
59d faster than avg
Panel avg: 107d · This submission: 48d
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 Sud 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 607
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K073238.
CARDIQ EXPRESS VERSION 2.0
K073138 · GE Medical Systems · Feb 2008
CARDIQ FUNCTION XPRESS
K073153 · GE Medical Systems SCS · Feb 2008
SYNGO DUAL ENERGY WITH EXTENDED FUNCTIONALLY
K073003 · Siemens Medi Cal Solutions, Inc. · Feb 2008
SYNGO VOLUME PERFUSION-CT BODY
K073373 · Siemens AG Medical Solutions · Dec 2007
CSNP-001A NEURO PACKAGE
K072693 · Toshiba America Medical Systems, In.C · Nov 2007
CSCS-001A CALCIUM SCORING PACKAGE
K072737 · Toshiba America Medical Systems, In.C · Oct 2007