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Biograph mCT Flow 40-3R
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 10529158Model PET-CT_11_IIb_HES
Identity
- Trade Name
- Biograph mCT Flow 40-3R EUDAMEDFDA UDI
- Generic Name
- PET/CT system FDA UDI
- Device Name
- PET-CT_11_IIb_HES EUDAMED
- Model / Reference
- 10529158 EUDAMEDFDA UDIPET-CT_11_IIb_HES EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04056869001395 EUDAMEDFDA UDI
- Basic UDI-DI
- 0405686900133UP EUDAMED
- 510(k) Number
- K151486 FDA UDI
- FDA Product Code
- KPS FDA UDI
- EMDN Code
- Z11020301 CT/PET SYSTEMS EUDAMED
- GMDN Term
- PET/CT system FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1200 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Biograph mCT Flow 40-3R by Siemens Medical Solutions Usa, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — 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
K151486 also covers:
- Advanced Workflow (MIWP) - mCT — SIEMENS MEDICAL SOLUTIONS USA, INC.
- Advanced Workflow (MIWP) - mCT Flow — SIEMENS MEDICAL SOLUTIONS USA, INC.
- Advanced Workflow (MIWP) - mCT Flow Edge — SIEMENS MEDICAL SOLUTIONS USA, INC.
- Advanced Workflow (MIWP) - mCT non-Flow — SIEMENS MEDICAL SOLUTIONS USA, INC.
- Biograph Remote Workstation VG50A — SIEMENS MEDICAL SOLUTIONS USA, INC.
- PET 6.0.1 Remote Recon W/S Kit — SIEMENS MEDICAL SOLUTIONS USA, INC.
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| 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 (2)
- FDA UDI ac8cc034-028c-437d-92c1-73fe3c894345 35 fields · synced Jun 18, 2026
- EUDAMED 2b401dcb-ec1a-4d1b-8410-685e2784510f 61 fields · synced Jun 18, 2026