Identity
- Trade Name
- syngo.MR BreVis FDA UDI
- Generic Name
- MRI system application software FDA UDI
- Device Name
- SW Version VB20 FDA UDI
- Model / Reference
- 11291463 FDA UDI
- Description
- SW Version VB20 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04056869043210 FDA UDI
- 510(k) Number
- K133401 FDA UDI
- FDA Product Code
- LLZ FDA UDILNH FDA UDI
- GMDN Term
- MRI system application software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.2050 FDA UDI892.1000 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 BreVis by Siemens Healthcare — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K133401 also covers:
- syngo.MR BreVis — Siemens Healthcare
- syngo.MR BreVis — Siemens Healthcare
- syngo.MR Neurology — Siemens Healthcare
- syngo.MR Neurology — Siemens Healthcare
- syngo.MR Neurology — Siemens Healthcare
- syngo.MR Oncology — Siemens Healthcare
- syngo.MR Oncology — Siemens Healthcare
- syngo.MR Oncology — Siemens Healthcare
- syngo.mMR General — Siemens Healthcare
- syngo.mMR General — Siemens Healthcare
- syngo.mMR General — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Siemens Healthcare
Sources (1)
- FDA UDI 63bdb487-fe30-42c2-bda2-b7d5adda6341 35 fields · synced Jun 1, 2026