FDA.reportPublic FDA data

WorkstationOne™

Primary DI
B148WSONE1850
Brand
WorkstationOne™
Company
THREE PALM SOFTWARE
Model
1.8.5
Device 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.
Published
2017-10-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
LLZSystem, Image Processing, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K073272000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K073272000WORKSTATIONONE BREAST IMAGING WORKSTATIONThree Palm Software, LLC2007-12-11LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B148WSONE1850PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Radiology picture archiving and communication system workstationA freestanding, image processing device that is a component of a picture archiving and communication system (PACS) for radiology designed to be networked with a wide variety of diagnostic imaging systems [e.g., x-ray, nuclear medicine, magnetic resonance imaging (MRI) or ultrasound (US), as well as a laboratory or hospital information system (HIS)]. It does not contain controls for the direct operation of a diagnostic imaging system and is designed to receive, archive, and transmit data both on-line and off-line. It is configured to provide limited or extensive capabilities to further process, manipulate and/or view patient images and information collected from diagnostic imaging systems.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(408) 356-3240support@threepalmsoft.com

Regulatory Flags#

DUNS number
793216669
Device count
1
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B148WSONE1940WorkstationOne™1.9.42025-08-13
B148WSONE1930WorkstationOne™1.9.32024-03-08
B148WSONE1920WorkstationOne™1.9.22023-08-22
B148WSONE1910WorkstationOne™1.9.12022-07-22
B148WSONE1900WorkstationOne™1.9.02021-04-23
B148WSONE1890WorkstationOne™1.8.92020-05-28
B148WSONE1880WorkstationOne™1.8.82019-06-04
B148WSONE1870WorkstationOne™1.8.72018-09-25
B148WSONE1810WorkstationOne™1.8.12016-07-27
B148WSONE1820WorkstationOne™1.8.22016-11-16
B148WSONE1830WorkstationOne™1.8.32017-05-17
B148WSONE1840WorkstationOne™1.8.42017-06-15
B148WSONE1860WorkstationOne™1.8.62018-02-25

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Primary DI, Brand, Company table
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