5 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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SoftLab Software Laboratory information system to be used in a medical research or clinical laboratory by knowledgeable, trained,
FDA Enforcement
Class II
·Terminated·Soft Computer Consultants, Inc.·August 9, 2017
SCC Soft Computer Softbank II software Product Usage: Supports single and multi-site transfusion services in healthcare facilities. Used by healthcare personal to document, query, and view the integrated information regarding patients and products. Quality control testing, test and transfusion history, transfusion management, inventory management, product distribution, and final disposition are all monitored using the software.
FDA Enforcement
Class II
·Terminated·Soft Computer Consultants, Inc.·February 1, 2017
Softbank software Product Usage: Decision support software for transfusion service. It keeps track of inventory from outside sources, multi-site inventory control, records of testing of units, and allows for record keeping for transfusion preparation.
FDA Enforcement
Class II
·Terminated·Soft Computer Consultants, Inc.·February 1, 2017
SoftCytogenetics
FDA Enforcement
Class II
·Terminated·Soft Computer Consultants, Inc.·July 28, 2021
SoftGenomics version 4.1.15.6 SoftGenomics is a laboratory workflow and information management system to be used in a clinical molecular or cytogenetics laboratory or medical research laboratory setting by knowledgeable and trained users. SoftGenomics is used to record and track activities performed in ordering, specimen processing (pre-analytical steps), testing, documentation, and reporting.
FDA Enforcement
Class II
·Terminated·Soft Computer Consultants, Inc.·July 28, 2021