Identity
- Trade Name
- TOP LEVEL BIOGRAPH 6-4R W/0 CT FDA UDI
- Generic Name
- PET/CT system FDA UDI
- Model / Reference
- 10245859 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04056869001715 FDA UDI
- 510(k) Number
- K141971 FDA UDI
- FDA Product Code
- KPS FDA UDI
- GMDN Term
- PET/CT system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1200 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: PET/CT system
Top Level Biograph 6-4r W/0 Ct by Siemens Medical Solutions Usa, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as PET/CT system.
- PET-CT SCANNER — Canon Medical Systems Corporation · Class II
- uMI — Shanghai United Imaging Healthcare Co., Ltd. · Class II
- uMI VM — UIH TECHNOLOGIES, LLC · Class II
- uMI — UIH TECHNOLOGIES, LLC · Class II
- TOSHIBA SCANNER — Canon Medical Systems Corporation · Class II
- uMI — Shanghai United Imaging Healthcare Co., Ltd. · Class II
- PET 6.0.1 Remote Recon W/S Kit — SIEMENS MEDICAL SOLUTIONS USA, INC. · Class II
- TOP LEVEL BIOGRAPH 40-4R W/0 CT — SIEMENS MEDICAL SOLUTIONS USA, INC. · Class II
Cleared under the same submission
K141971 also covers:
- BIOGRAPH Advanced Workflow (B16) — SIEMENS MEDICAL SOLUTIONS USA, INC.
- Biograph 16 TruePoint - 3R — SIEMENS MEDICAL SOLUTIONS USA, INC.
- Biograph 16 TruePoint TrueV - 4R — SIEMENS MEDICAL SOLUTIONS USA, INC.
- Biograph Advanced Workflow (B6) — SIEMENS MEDICAL SOLUTIONS USA, INC.
- Biograph Advanced Workflow (B64/40) — SIEMENS MEDICAL SOLUTIONS USA, INC.
- TOP LEVEL BIOGRAPH 40-3R W/0 CT — SIEMENS MEDICAL SOLUTIONS USA, INC.
- TOP LEVEL BIOGRAPH 40-4R W/0 CT — SIEMENS MEDICAL SOLUTIONS USA, INC.
- TOP LEVEL BIOGRAPH 6-3R W/0 CT — SIEMENS MEDICAL SOLUTIONS USA, INC.
- TOP LEVEL BIOGRAPH 64-3R W/0 CT — SIEMENS MEDICAL SOLUTIONS USA, INC.
- TOP LEVEL BIOGRAPH 64-4R W/O CT — SIEMENS MEDICAL SOLUTIONS USA, INC.
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 Medical Solutions Usa, Inc.
Sources (1)
- FDA UDI 45ab19cf-bee5-4723-bf00-18d80f6828be 35 fields · synced Jun 8, 2026