Identity
- Trade Name
- syngo.via FDA UDI
- Generic Name
- Radiology DICOM image processing application software FDA UDI
- Device Name
- syngo.via VB10B"Stock Keeping Unit B" - product label DVD Media CoverThis unit contains the following registered Medical Devices:(1) syngo.via - GTIN 04056869007045(2) syngo.interventional - GTIN 04056869020518(3) syngo.CT Coronary Analysis - GTIN 04056869013855(4) syngo.CT Cardiac Function - GTIN 04056869013862(5) syngo.CT CaScoring - GTIN 04056869013879(6) syngo.CT Vascular Analysis - GTIN 04056869013886(7) syngo.CT Colonography - GTIN 04056869013893(8) syngo.CT Pulmo3D - GTIN 04056869013909(9 FDA UDI
- Model / Reference
- 11250036 FDA UDI
- Description
- syngo.via VB10B"Stock Keeping Unit B" - product label DVD Media CoverThis unit contains the following registered Medical Devices:(1) syngo.via - GTIN 04056869007045(2) syngo.interventional - GTIN 04056869020518(3) syngo.CT Coronary Analysis - GTIN 04056869013855(4) syngo.CT Cardiac Function - GTIN 04056869013862(5) syngo.CT CaScoring - GTIN 04056869013879(6) syngo.CT Vascular Analysis - GTIN 04056869013886(7) syngo.CT Colonography - GTIN 04056869013893(8) syngo.CT Pulmo3D - GTIN 04056869013909(9 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04056869020884 FDA UDI
- 510(k) Number
- K150843 FDA UDI
- FDA Product Code
- LLZ FDA UDI
- GMDN Term
- Radiology DICOM image processing application software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.2050 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Radiology DICOM image processing application software
syngo.via by Siemens Healthcare — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Siemens Healthcare
Sources (1)
- FDA UDI 5140d92a-9c41-4df9-beeb-952769d61c41 35 fields · synced May 30, 2026