Identity
- Trade Name
- Synapse 3D FDA UDI
- Generic Name
- Radiology picture archiving and communication system workstation FDA UDI
- Device Name
- The product “Synapse 3D” is a system that receives and retrieves DICOM data from modalities including CT, MR, PET, XA, etc. and constructs 3D images and performs image analysis. FDA UDI
- Model / Reference
- Synapse 3D FDA UDI
- Description
- The product “Synapse 3D” is a system that receives and retrieves DICOM data from modalities including CT, MR, PET, XA, etc. and constructs 3D images and performs image analysis. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04547410324877 FDA UDI
- 510(k) Number
- K120637 FDA UDIK120679 FDA UDIK123566 FDA UDIK130542 FDA UDIK141514 FDA UDIK142521 FDA UDIK162287 FDA UDIK181773 FDA UDIK191544 FDA UDIK200973 FDA UDIK221677 FDA UDI
- FDA Product Code
- JAK FDA UDILLZ FDA UDI
- GMDN Term
- Radiology picture archiving and communication system workstation FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1750 FDA UDI892.2050 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
Yes
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: Radiology picture archiving and communication system workstation
Synapse 3D by FUJIFILM Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- FUJIFILM Corporation
Sources (1)
- FDA UDI d45bac45-e6f2-4a18-b090-f5cfd358bf78 35 fields · synced May 31, 2026