Eu Mdr Eu Md Class 1 On The Market 🇺🇸 United States

WorkstationOne

Three Palm Software · 🇺🇸 United States
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0

Basic Information

Primary DI
B148WSONE1910
Basic UDI-DI Code
++B148WSONE1919U
Reference
1.9.1
Device Types
None provided
Regulation
Eu Mdr
Classification
Eu Md Class 1
Status
On The Market
Manufacturer
Three Palm Software

Additional 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 tasks. The workstation can also interface with a reporting system to generate an interpretation report. Optionally, the workstation supports media exchange and film printing.

CND Nomenclature Codes

Code Description
Z11069005 DIAGNOSTIC IMAGING WORKSTATIONS

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