Cleared Traditional

K163341 - syngo.CT Extended Functionality

K163341 is an FDA 510(k) clearance for syngo.CT Extended Functionality, manufactured by Siemens Medical Solutions USA, Inc.. The device is a Class 2 Radiology device with product code JAK cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K163341 · Siemens Medical Solutions USA, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2017
Decision
72d
Days
Class 2
Risk

K163341 is an FDA 510(k) clearance for the syngo.CT Extended Functionality. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Siemens Medical Solutions USA, Inc. (Malvern, US). The FDA issued a Cleared decision on February 9, 2017 after a review of 72 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 Medical Solutions USA, Inc. devices

FDA 510(k) Submission Details - K163341

510(k) Number K163341 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 2016
Decision Date February 09, 2017
Days to Decision 72 days
Submission Type Traditional
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
35d faster than avg
Panel avg: 107d · This submission: 72d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 722
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K163341.
HITACHI Supria Whole-body X-ray CT System Phase 3
K163528 · Hitachi Medical Systems America, Inc. · Mar 2017
syngo. CT Neuro Perfusion
K163284 · Siemens Medical Solutions USA, Inc. · Mar 2017
syngo. CT Single Source Dual Energy (twin beam)
K163289 · Siemens Medical Solutions USA, Inc., Ultrasound DI · Feb 2017
Aquilion Lightning, TSX-036A/1, V8.4
K170019 · Toshibamedical Systems Corporation · Feb 2017
FastStroke
K163281 · Gef Medical Systems Scs · Jan 2017
Somatom Confidence ® RT Pro
K162302 · Siemens Medical Solutions USA, Inc. · Dec 2016