Identity
- Trade Name
- WorkstationOne EUDAMEDWorkstationOne™ FDA UDI
- Generic Name
- Radiology picture archiving and communication system workstation FDA UDI
- Device Name
- WorkstationOne EUDAMEDWorkstationOne is a vendor-neutral diagnostic breast imaging workstation which consists of a software system that obtains breast imaging screening or diagnosis exams from PACS (Picture Archiving and Communication System) or Modalities; displays and manipulates the images for radiologists to perform interpretation task. The workstation can also interface with a reporting system to generate an interpretation report. Optionally, the workstation supports media exchange and film printing. FDA UDI
- Model / Reference
- 1.9.2 EUDAMEDFDA UDIWS1 EUDAMED
- Description
- WorkstationOne is a vendor-neutral diagnostic breast imaging workstation which consists of a software system that obtains breast imaging screening or diagnosis exams from PACS (Picture Archiving and Communication System) or Modalities; displays and manipulates the images for radiologists to perform interpretation task. The workstation can also interface with a reporting system to generate an interpretation report. Optionally, the workstation supports media exchange and film printing. FDA UDI
Identifiers
- Primary DI / UDI-DI
- B148WSONE1920 EUDAMEDFDA UDI
- Basic UDI-DI
- ++B148WSONE1929W EUDAMED
- Direct Marketing DI
- B148WSONE1920 EUDAMED
- 510(k) Number
- K073272 FDA UDI
- FDA Product Code
- LLZ FDA UDI
- EMDN Code
- Z11069005 DIAGNOSTIC IMAGING WORKSTATIONS EUDAMED
- GMDN Term
- Radiology picture archiving and communication system workstation FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.2050 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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Tissue specimen x-ray system IVD
WorkstationOne by Three Palm Software — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Tissue specimen x-ray system IVD.
- Myrian® 2.12 : XP-Cardiac CT — INTRASENSE · Class IIa
- coDiagnostiX — Dental Wings GmbH · Class IIa
- Myrian® 2.13 : XP-Liver — INTRASENSE · Class IIa
- Myrian® 2.13 : XM-CT — INTRASENSE · Class IIa
- Stacja przeglądowa cyfrowych i analogowych obrazów Rtg typu DiCO 2M/2B — ULTRA-VIOL Pietras Purgał Wójcik Spółka Jawna · Class I
- Clarix Imaging Corps — Clarix Imaging · Class II
- Myrian® 2.12 : XP-AbdoFat — INTRASENSE · Class IIa
- NEGATOSKOP(TRIPLE) — TUR-MED HASTANE MALZ. SAN. TIC. LTD. ŞTI. · Class I
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 | ++B148WSONE1929W | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Three Palm Software
- EUDAMED SRN
- US-MF-000002924
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (2)
- EUDAMED 927e1653-d8b5-4989-8696-6ef35dd634af 61 fields · synced Jul 14, 2026
- FDA UDI 460e81c6-5f8c-43f5-bd9b-37dd83449237 35 fields · synced May 30, 2026