Identity
- Trade Name
- Fusion Bx FDA UDI
- Generic Name
- Radiology picture archiving and communication system workstation FDA UDI
- Device Name
- Fusion Bx EUDAMEDFusion Bx 2.0 is designed to display the 2D live video received from commercially available ultrasound machines and use this 2D video to reconstruct a 3D ultrasound image volume. The system is designed to work with clinicians’ existing ultrasound machines, transrectal ultrasound (TRUS) probes, commercially available needles, needle guides/templates and needle gun combination. Additional software features include patient data management, multi-planar reconstruction, segmentation, image measurements and 3D image registration. Fusion Bx 2.0 offers the physician additional 3D information for assessing prostate abnormalities, planning and implementing biopsy procedures. The additional image processing features are generated with minimal changes to previous TRUS probe-based procedures, and the physician always has access to the live 2D ultrasound image during prostate assessment or biopsy procedure. FDA UDI
- Model / Reference
- 2.0 EUDAMEDFDA UDI
- Description
- Fusion Bx 2.0 is designed to display the 2D live video received from commercially available ultrasound machines and use this 2D video to reconstruct a 3D ultrasound image volume. The system is designed to work with clinicians’ existing ultrasound machines, transrectal ultrasound (TRUS) probes, commercially available needles, needle guides/templates and needle gun combination. Additional software features include patient data management, multi-planar reconstruction, segmentation, image measurements and 3D image registration. Fusion Bx 2.0 offers the physician additional 3D information for assessing prostate abnormalities, planning and implementing biopsy procedures. The additional image processing features are generated with minimal changes to previous TRUS probe-based procedures, and the physician always has access to the live 2D ultrasound image during prostate assessment or biopsy procedure. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00628055858010 EUDAMEDFDA UDI
- Basic UDI-DI
- 62805585801SF EUDAMED
- Direct Marketing DI
- 00628055858010 EUDAMED
- 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
- Market of Registration
- Belgium 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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Fusion Bx by Focal Healthcare Inc — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K153166 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K181290 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 62805585801SF | Class IIa | Active |
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Manufacturer
- Manufacturer
- Focal Healthcare Inc
- EUDAMED SRN
- CA-MF-000050812
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (3)
- EUDAMED a1943ca6-96f9-4d76-94b6-114a5270250c 61 fields · synced Jun 20, 2026
- FDA UDI 851ab1f4-b6a9-4c00-bd99-cac7664ae0a9 33 fields · synced May 30, 2026
- FDA 510(k) K153166 1 fields · synced May 18, 2026