syngo.CT Cardiac Planning
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- syngo.CT Cardiac Planning EUDAMED
- Device Name
- syngo.CT PP_IIb_App_ERLN H 127 EUDAMED
- Model / Reference
- syngo.CT PP_IIb_App_ERLN H 127 EUDAMED11546319 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04056869267432 EUDAMED
- Basic UDI-DI
- 0405686901998X2 EUDAMED
- 510(k) Number
- K170221 FDA 510(k)
- FDA Product Code
- JAK FDA 510(k)
- EMDN Code
- Z11030692 COMPUTED TOMOGRAPHS (CT) - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1750 FDA 510(k)
- Regulation Number
- 892.1750 FDA 510(k)
- Special Device Type
- Software EUDAMED
- Market of Registration
- Germany EUDAMED
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
syngo.CT Cardiac Planning is a Cardiac Imaging Software designed for pre-procedural planning in cardiac interventions. It integrates computed tomography (CT) data to enable precise anatomical assessment, facilitating tailored treatment strategies for coronary artery disease and related conditions. The software automates key pre-processing steps, such as artifact reduction and segmentation, to enhance diagnostic clarity and efficiency.
This device is supplied as a software solution for use in radiology and cardiac catheterization laboratories, requiring integration with compatible CT imaging systems. It is intended for single-use per imaging session, with no explicit sterility requirements stated. The software adheres to FDA 510(k) clearance and MDR compliance, ensuring regulatory alignment for clinical deployment. No MRI safety classifications or physical size specifications are provided in the available data.
Frequently asked questions
What is the primary purpose of syngo.CT Cardiac Planning?
This software is designed for pre-procedural planning in cardiac interventions, integrating CT data to enable precise anatomical assessment and facilitate tailored treatment strategies for coronary artery disease and related conditions.
How is syngo.CT Cardiac Planning supplied and where should it be used?
It is supplied as a software solution for use in radiology and cardiac catheterization laboratories, requiring integration with compatible CT imaging systems.
Can syngo.CT Cardiac Planning be reused for multiple imaging sessions?
The software is intended for single-use per imaging session, with no explicit sterility requirements stated in the available data.
What regulatory approvals does syngo.CT Cardiac Planning have?
The software adheres to FDA 510(k) clearance and MDR compliance, ensuring regulatory alignment for clinical deployment.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: syngo.CT Coronary Analysis - Siemens Healthineers, syngo.CT Coronary Analysis - Siemens Healthineers USA, Siemens Healthineers unveils new AI-powered CCTA software
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K170221 | Class II | Active |
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Manufacturer
- Manufacturer
- Siemens Healthcare GmbH
Sources (2)
- FDA 510(k) K170221 24 fields · synced Oct 6, 2026
- EUDAMED 0e804917-b53d-4aea-b7d8-e67a0a7aa969 61 fields · synced Jul 16, 2026