Identity
- Trade Name
- syngo.MR Vascular FDA UDI
- Generic Name
- MRI system application software FDA UDI
- Device Name
- SW version VA30B FDA UDI
- Model / Reference
- 11234867 FDA UDI
- Description
- SW version VA30B FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04056869012773 FDA UDI
- 510(k) Number
- K130749 FDA UDI
- FDA Product Code
- LNH FDA UDILLZ FDA UDI
- GMDN Term
- MRI system application software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1000 FDA UDI892.2050 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: MRI system application software
syngo.MR Vascular by Siemens Healthcare — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K130749 also covers:
- syngo.MR Cardiology — Siemens Healthcare
- syngo.MR Cardiology — Siemens Healthcare
- syngo.MR Cardiology — Siemens Healthcare
- syngo.MR General — Siemens Healthcare
- syngo.MR General — Siemens Healthcare
- syngo.MR General — Siemens Healthcare
- syngo.MR Vascular — Siemens Healthcare
- syngo.MR Vascular — Siemens Healthcare
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 b4fe592d-c284-4e9b-8f7d-c6020e15fdf6 35 fields · synced Jun 8, 2026