WorkstationOne™

GUDID B148WSONE1880

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.

THREE PALM SOFTWARE

Radiology picture archiving and communication system workstation

• Primary Device ID: B148WSONE1880
• NIH Device Record Key: cb39d555-fd9a-4473-9de7-e3fffee2debe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WorkstationOne™
• Version Model Number: 1.8.8
• Company DUNS: 793216669
• Company Name: THREE PALM SOFTWARE
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (408) 356-3240
• Email: support@threepalmsoft.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B148WSONE1880 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K073272

FDA Product Code

• LLZ: System, Image Processing, Radiological

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-06-12
• Device Publish Date: 2019-06-04

On-Brand Devices [WorkstationOne™]

• B148WSONE1870: WorkstationOne is a vendor-neutral diagnostic breast imaging workstation which consists of a sof
• B148WSONE1860: WorkstationOne is a vendor-neutral diagnostic breast imaging workstation which consists of a sof
• B148WSONE1850: WorkstationOne is a vendor-neutral diagnostic breast imaging workstation which consists of a sof
• B148WSONE1840: WorkstationOne is a vendor-neutral diagnostic breast imaging workstation which consists of a sof
• B148WSONE1830: WorkstationOne is a vendor-neutral diagnostic breast imaging workstation which consists of a sof
• B148WSONE1820: WorkstationOne is a vendor-neutral diagnostic breast imaging workstation which consists of a sof
• B148WSONE1810: WorkstationOne is a vendor-neutral diagnostic breast imaging workstation which consists of a sof
• B148WSONE1880: WorkstationOne is a vendor-neutral diagnostic breast imaging workstation which consists of a sof
• B148WSONE1900: WorkstationOne is a vendor-neutral diagnostic breast imaging workstation which consists of a sof
• B148WSONE1910: WorkstationOne is a vendor-neutral diagnostic breast imaging workstation which consists of a sof
• B148WSONE1920: WorkstationOne is a vendor-neutral diagnostic breast imaging workstation which consists of a sof
• B148WSONE1930: WorkstationOne is a vendor-neutral diagnostic breast imaging workstation which consists of a sof