Identity
- Trade Name
- Synapse CV EUDAMEDSynapse Cardiology PACS FDA UDI
- Generic Name
- Radiology picture archiving and communication system workstation FDA UDI
- Device Name
- Synapse CV EUDAMEDDeveloped with direction from cardiologists, Synapse Cardiovascular offers capabilities and tools that help streamline workflow, image review, and reporting for a variety of cardiac areas. FDA UDI
- Model / Reference
- Synapse CV EUDAMEDSynapse Cardiology PACS Software License FDA UDI
- Description
- Developed with direction from cardiologists, Synapse Cardiovascular offers capabilities and tools that help streamline workflow, image review, and reporting for a variety of cardiac areas. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00854904006015 EUDAMEDFDA UDI
- Basic UDI-DI
- 0854904006HCUSCV6Z EUDAMED
- 510(k) Number
- K151859 FDA UDI
- FDA Product Code
- LLZ FDA UDI
- EMDN Code
- Z110603 PICTURE ARCHIVING AND COMMUNICATION SYSTEMS EUDAMED
- GMDN Term
- Radiology picture archiving and communication system workstation FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.2050 FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- Germany 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Synapse CV by FUJIFILM Healthcare Americas Corporation — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0854904006HCUSCV6Z | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- FUJIFILM Healthcare Americas Corporation
- EUDAMED SRN
- US-MF-000009244
- Authorised Representative
- FUJIFILM Healthcare Europe GmbH DE-AR-000040920
Sources (2)
- EUDAMED 2e9a2f2f-792c-4952-98a9-bd588d1baca5 61 fields · synced Jun 18, 2026
- FDA UDI 0790ffd1-2acd-4c20-8171-2652122f73b2 35 fields · synced May 29, 2026