Cleared Traditional

K163289 - syngo. CT Single Source Dual Energy (twin beam)

K163289 is an FDA 510(k) clearance for syngo. CT Single Source Dual Energy (tw..., manufactured by Siemens Medical Solutions USA, Inc., Ultrasound DI. The device is a Class 2 Radiology device with product code JAK cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K163289 · Siemens Medical Solutions USA, Inc., Ultrasound DI · Radiology device
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Feb 2017
Decision
79d
Days
Class 2
Risk

K163289 is an FDA 510(k) clearance for the syngo. CT Single Source Dual Energy (twin beam). Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Siemens Medical Solutions USA, Inc., Ultrasound DI (Malvern, US). The FDA issued a Cleared decision on February 9, 2017 after a review of 79 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., Ultrasound DI devices

FDA 510(k) Submission Details - K163289

510(k) Number K163289 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 2016
Decision Date February 09, 2017
Days to Decision 79 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
28d faster than avg
Panel avg: 107d · This submission: 79d
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
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