syngo.via

Basic Information

• Brand Name: syngo.via
• Primary DI: 04056869033686
• Version / Model: 11298690
• Company Name: Siemens Healthcare GmbH
• Labeler DUNS: 313217003
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 8
• Public Version Date: 2023-12-04
• Public Version Status: Update
• Public Device Record Key: 5774a6e9-6db1-4e9a-ac80-321ba9dff3e0

Device Description

syngo.via VA30B "Stock Keeping Unit B" - product label DVD Media Cover: This unit contains the following registered Medical Devices:(1) syngo.via GTIN 04056869020976 (2) syngo.interventional GTIN 04056869020501 (3) syngo.CT Coronary Analysis GTIN 04056869007762(4) syngo.CT Cardiac Function - GTIN 04056869007779 (5) syngo.CT CaScoring - GTIN 04056869007786 (6) syngo.CT Vascular AnalysisGTIN 04056869007793 (7) syngo.CT Colonography - GTIN 04056869007809 (8) syngo.CT Pulmo3D - GTIN 04056869007816 (

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LLZ	System, image processing, radiological	Radiology	892.2050	2

GMDN Terms

Code	Name	Definition	Implantable	Status
57812	Radiology DICOM image processing application software	A software application intended to facilitate management, distribution, and/or viewing of radiological digital imaging and communications in medicine (DICOM) image data; it is not intended for pathological image interpretation (i.e., not intended to detect and localize suspected abnormalities). It may be intended to facilitate image management (e.g., viewing, communication, printing, recording/disc burning) and/or image quality manipulation and quantification (e.g., non-interpretive graphical overlays).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04056869033686	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K123920	000