Cleared Traditional

K162302 - Somatom Confidence RT Pro

K162302 is the FDA 510(k) clearance for Somatom Confidence RT Pro by Siemens Medical Solutions USA, Inc.. It is a Class 2 Radiology device (product code JAK) cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K162302 · Siemens Medical Solutions USA, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2016
Decision
121d
Days
Class 2
Risk

K162302 is an FDA 510(k) clearance for the Somatom Confidence ® RT Pro. 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 December 16, 2016 after a review of 121 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Siemens Medical Solutions USA, Inc. devices

Submission Details

510(k) Number K162302 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 2016
Decision Date December 16, 2016
Days to Decision 121 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
14d slower than avg
Panel avg: 107d · This submission: 121d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Peers - JAK System, X-ray, Tomography, Computed

All 581
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K162302.
syngo. CT Neuro Perfusion
K163284 · Siemens Medical Solutions USA, Inc. · Mar 2017
syngo.CT Extended Functionality
K163341 · Siemens Medical Solutions USA, Inc. · Feb 2017
Aquilion Lightning, TSX-036A/1, V8.4
K170019 · Toshibamedical Systems Corporation · Feb 2017
Revolution CT
K163213 · Ge Medical Systems, LLC · Dec 2016
Vitrea CT Dual Energy Image View
K161157 · Vital Images, Inc. · Nov 2016
OnSight 3D Extremity System
K160723 · Carestream Health, Inc. · Aug 2016