Cleared Traditional

K170221 - syngo.CT Cardiac Planning

K170221 is the FDA 510(k) clearance for syngo.CT Cardiac Planning by Siemens Healthcare GmbH. It is a Class 2 Radiology device (product code JAK) cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K170221 · Siemens Healthcare GmbH · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2017
Decision
86d
Days
Class 2
Risk

K170221 is an FDA 510(k) clearance for the syngo.CT Cardiac Planning. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Siemens Healthcare GmbH (Forchheim, DE). The FDA issued a Cleared decision on April 21, 2017 after a review of 86 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 Healthcare GmbH devices

Submission Details

510(k) Number K170221 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 2017
Decision Date April 21, 2017
Days to Decision 86 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
21d faster than avg
Panel avg: 107d · This submission: 86d
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.
George Bauer

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 604
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K170221.
OnSight 3D Extremity System
K173478 · Carestream Health, Inc. · Jan 2018
Philips CT Big Bore
K171850 · Philips Medical Systems (Cleveland), Inc. · Nov 2017
Aquilion ONE (TSX-305A/3) V8.3 with FIRST 2.1
K170177 · Toshibamedical Systems Corporation · Jun 2017
PercuNav Image Fusion and Interventional Navigation
K170716 · Philips Ultrasound, Inc. · Apr 2017
Philips iCT CT System
K162838 · Philips Medical Systems (Cleveland), Inc. · Apr 2017
IQon Spectral CT
K163711 · Philips Medical Systems (Cleveland), Inc. · Apr 2017