Cleared Traditional

K071310 - SYNGO CT ONCOLOGY SOFTWARE PACKAGE

K071310 is an FDA 510(k) clearance for SYNGO CT ONCOLOGY SOFTWARE PACKAGE, manufactured by Siemens AG. The device is a Class 2 Radiology device with product code JAK cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K071310 · Siemens AG · Radiology device
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Optimized for regulatory review, auditing and printing
Jun 2007
Decision
30d
Days
Class 2
Risk

K071310 is an FDA 510(k) clearance for the SYNGO CT ONCOLOGY SOFTWARE PACKAGE. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Siemens AG (Forchheim, Bavaria, DE). The FDA issued a Cleared decision on June 8, 2007 after a review of 30 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 devices

FDA 510(k) Submission Details - K071310

510(k) Number K071310 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 2007
Decision Date June 08, 2007
Days to Decision 30 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 107d · This submission: 30d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

JAK Device Classification - Class 2, Special Controls

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 646
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K071310.
ECLOS COMPUTED TOMOGRAPHY X-RAY SYSTEM
K071806 · Hitachi Medical Systems America, Inc. · Aug 2007
MODIFICATION TO NEUVIZ DUAL MULTI-SLICE CT SCANNER SYSTEM
K071308 · Neusoft Medical Systems Co., Ltd. · Aug 2007
MODIFICATION TO EMPOWER CT/CTA INJECTOR SYSTEM, MODELS 9800/9900 PRODUCT SERIES
K071378 · E-Z-Em, Inc. · Jun 2007
PET VCAR
K063324 · Ge Healthcare · Mar 2007
SYNGO CIRCULATION SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY
K063762 · Siemens AG Medical Solutions · Jan 2007
CSTC-002A, EXTENDED FIELD OF VIEW SOFTWARE OPTION
K063241 · Toshiba America Medical Systems, In.C · Nov 2006