Identity
- Trade Name
- Scenium SPECT_V FDA UDI
- Generic Name
- SPECT system application software FDA UDI
- Model / Reference
- 10183311 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04056869002392 FDA UDI
- FDA Product Code
- LLZ FDA UDI
- GMDN Term
- SPECT 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: SPECT system application software
Scenium SPECT_V by Siemens Medical Solutions Usa, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as SPECT system application software.
- UltraSPECT — ULTRASPECT USA, LLC · Class II
- UltraSPECT — ULTRASPECT USA, LLC · Class II
- UltraSPECT — ULTRASPECT USA, LLC · Class II
- UltraSPECT — ULTRASPECT USA, LLC · Class II
- UltraSPECT — ULTRASPECT USA, LLC · Class II
- UltraSPECT — ULTRASPECT USA, LLC · Class II
- UltraSPECT — ULTRASPECT USA, LLC · Class II
- ImagenSPECT — CARDIOVASCULAR IMAGING TECHNOLOGIES L.L.C. · Class II
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 d83a99da-1455-4515-815e-4ba2295c238c 33 fields · synced Jun 8, 2026