Identity
- Trade Name
- syngo MBF FDA UDI
- Generic Name
- PET system application software FDA UDI
- Model / Reference
- 10764036 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04056869002088 FDA UDI
- 510(k) Number
- K110494 FDA UDI
- FDA Product Code
- LLZ FDA UDI
- GMDN Term
- PET system 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: PET system application software
syngo MBF by Siemens Medical Solutions Usa, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as PET system application software.
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- syngo.MI General — SIEMENS MEDICAL SOLUTIONS USA, INC. · Class II
- syngo Scenium SPECT — SIEMENS MEDICAL SOLUTIONS USA, INC. · Class II
- syngo.PET&CT Oncology — SIEMENS MEDICAL SOLUTIONS USA, INC. · Class II
- SW-Key: NMG_SCENIUM_ADV VIA — SIEMENS MEDICAL SOLUTIONS USA, INC. · Class II
Cleared under the same submission
K110494 also covers:
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 Medical Solutions Usa, Inc.
Sources (1)
- FDA UDI 13bed51d-5179-4b7f-8886-b479dc6bf241 34 fields · synced Jun 8, 2026