Version 3.1.4.x

Clinical Chemistry and Clinical Toxicology Devices

1

No

Worldwide Distribution -- US, including states of CT, FL, IL, KY, GA, LA, IN, MS, NJ, NY, PA, OH, and TN and country of Canada.

SA BASE with SoftLab Version 3.1.4.x. || Manufactured 03/2003. || SCC Soft Computer 5400 Tech Data Drive Clearwater, FL 33760. || Intends to provide clients with an interface that links all clinical laboratory departments throughout the enterprise.

SA HIS version 4.0.7.0

Clinical Chemistry and Clinical Toxicology Devices

1

No

Distributed in IL.

SCC SA HIS version 4.0.7.0 when used with SoftMic version 4.0.7.0. || SoftMic is a laboratory information system to be used in medical results, clinical, and public health laboratories by knowledgeable, trained, and experienced personnel. SoftMic enables the user to handle data processing and laboratory activities for microbiology and serology testing, for the purpose of storing, managing, querying, and reporting laboratory data.

Versions 23.1.2.x, 23.2.0.x, 25.0.0.x

Hematology and Pathology Devices

2

No

Worldwide distribution: U.S. and country of Canada.

SoftBank Versions 23.1.2.x, 23.2.0.x, and 25.0.0.x with SoftReports. || SCC Soft Computer 5400 Tech Data Drive Clearwater, FL 33760. || 23.1:BK040048 || 23.2:BK080020 || 25.0:BK090017 || The SoftBank II application, using SoftScape user interface, is a decision support software device that requires knowledgeable user intervention to document steps and events in a transfusion service. The application provides single and multiple site facilities the ability to manage their transfusion service by integrating patient and unit information. SoftBank uses an SCC proprietary interface called SoftScape that facilitates access to the application.

Versions: SoftID.NET 2.0.0.6 - 4/3/2007,  SoftID.NET 2.0.0.7 - 6/21/2007,  SoftID.NET 2.0.0.8 - 8/29/2007,  SoftID.NET 2.0.0.9 - 10/01/2007,  SoftID.NET 2.0.0.10 - 10/25/2007,  SoftID.NET 2.0.0.11 - 11/07/2007,  SoftID.NET 2.0.0.12 - 2/08/2008,  SoftID.NET 2.0.0.13 - 5/13/2008,  SoftID.NET 2.0.0.14 - 6/12/2008,  SoftID.NET 2.0.0.15 - 8/15/2008,  SoftID.NET 2.0.0.16 - 10/15/2008,  SoftID.NET 2.0.0.17 - 12/15/2008,  SoftID.NET 2.0.0.18 - 2/02/2009,  SoftID.NET 2.0.0.19 - 5/18/2009.

General Hospital and Personal Use Devices

Unclassified

No

Nationwide distribution: AR, CA, FL, IL, IN, KS,LA, MA, MI, MN, MO, NC, ND,NH, NJ, NY, OH, PA, RI, TN, TX, VA and WI.

SoftID.NET versions 2.0.0.6 - 2.0.0.19. || SCC Soft Computer 5400 Tech Data Drive Clearwater, FL 33760. || SoftID.NET is to be used in a medical or clinical laboratory setting by knowledgeable, trained, and experienced professionals. SoftID.NET supports bedside collection of patient specimens used in diagnostic testing. This product is integrated with Soft Computer's SoftLab, SoftScape and can also interface with all other SCC laboratory systems and Hospital Information Systems (HIS).

Softlab with DORA versions: 2.0.0.4 with Hot Fix 1.2808, 1.2809, 1.2956, or 1.3476; 2.0.0.5; 2.0.0.6; 2.0.0.7 with Hot Fix 1.6595; and 2.1.0.3.

General Hospital and Personal Use Devices

Unclassified

No

Sold throughout US and Canada.

SCC Soft Computer, Softlab Laboratory information System with DORA versions: 2.0.0.4 with Hot Fix 1.2808, 1.2809, 1.2956, or 1.3476; 2.0.0.5; 2.0.0.6; 2.0.0.7 with Hot Fix 1.6595; and 2.1.0.3.

SoftLab used with SA INST 4.0.2.0 to 4.0.2.51, 4.0.3.0 to 4.0.3.13, 4.5.0.0 to 4.5.0.9, 4.5.2.0 to 4.5.2.8 and SA INST 3.1.3.0 to 3.1.3.29, 3.1.6.0 to 3.1.6.17, 4.0.0.0, 4.0.1.0 to 4.0.1.32.

Clinical Chemistry and Clinical Toxicology Devices

1

No

Worldwide Distribution - USA (Nationwide) and Country of: Canada.

SoftLab used with SA INST 4.0.2.0 to 4.0.2.51, 4.0.3.0 to 4.0.3.13, 4.5.0.0 to 4.5.0.9, 4.5.2.0 to 4.5.2.8 and SA INST 3.1.3.0 to 3.1.3.29, 3.1.6.0 to 3.1.6.17, 4.0.0.0, 4.0.1.0 to 4.0.1.32. || SoftLab is a laboratory information system to be used in a medical research or clinical laboratory by knowledgeable, trained, and experienced personnel. SoftLab enables the user to handle data-processing and laboratory activities, for the purpose of storing, managing, querying, and reporting laboratory data.

Versions 4.5.4.3, 4.5.4.5, 4.5.4.6, 4.5.4.8, 4.5.4.9, 4.5.4.20, 4.5.4.30, 4.5.4.40, 4.5.5.0, 4.5.5.10, and 4.5.5.20

General Hospital and Personal Use Devices

Unclassified

No

US Distribution to states of: CA, IL, LA, MA, MD, MI, MN, NJ, NY, PA, and TX.

SoftLab Software || Laboratory information system to be used in a medical research or clinical laboratory by knowledgeable, trained,

SoftLab GUI versions: 3.18.1.0-3.18.1.21; 3.19.1.0-3.19.1.25; 3.19.2.0-3.19.2.21; 4.0.0.2; 4.0.1.0-4.0.1.16; 4.0.2.0-4.0.2.10; 4.0.3.0-4.0.3.16; 4.0.4.0-4.0.4.6; and 4.5.0.0-4.5.0.8.

Clinical Chemistry and Clinical Toxicology Devices

1

No

Worldwide Distribution - USA (nationwide) and the country of: Canada.

SoftLab GUI versions: 3.18.1.0-3.18.1.21; 3.19.1.0-3.19.1.25; 3.19.2.0-3.19.2.21; 4.0.0.2; 4.0.1.0-4.0.1.16; 4.0.2.0-4.0.2.10; 4.0.3.0-4.0.3.16; 4.0.4.0-4.0.4.6; and 4.5.0.0-4.5.0.8. || Product Usage: SoftLab is a laboratory information system to be used in a medical research or clinical laboratory by knowledgeable, trained, and experienced personnel. SoftLab enables the user to handle data-processing and laboratory activities, for the purpose of storing, managing, querying, and reporting laboratory data.

SoftLab GUI versions 4.0.2.8-4.0.2.10; 4.0.3.12-4.0.3.13; and 4.0.4.1-4.0.4.4.

General Hospital and Personal Use Devices

Unclassified

No

Worldwide Distribution-- USA ( nationwide) and Canada.

SoftLab GUI versions 4.0.2.8-4.0.2.10; 4.0.3.12-4.0.3.13; and 4.0.4.1-4.0.4.4. || SoftLab is a laboratory information system to be used in a medical research or clinical laboratory by knowledgeable, trained, and experienced personnel. SoftLab enables the user to handle data-processing and laboratory activities, for the purpose of storing, managing, querying, and report laboratory data.

Versions 4.0.1.14, 4.0.1.15, and 4.0.1.16.

Clinical Chemistry and Clinical Toxicology Devices

1

No

Nationwide Distribution - US and Puerto Rico.

SoftLab/Mic ASCII Add-on Versions 4.0.1.14, 4.0.1.15, and 4.0.1.16. || SCC Soft Computer 5400 Tech Data Drive Clearwater, FL 33760. || Version 4.0.1.14 Manufactured & Distributed 12/29/2006. || Version 4.0.1.15 Manufactured & Distributed 05/02/2007. || Version 4.0.1.16 Manufactured & Distributed 08/22/2008. || Used in a medical research or clinical laboratory setting by knowledgeable, trained and experienced personnel.

4.0.7.0: released 12/13/13 - present 4.0.7.1: released 02/28/14 - present

Clinical Chemistry and Clinical Toxicology Devices

1

No

Distributed US (nationwide) in the states of OH, GA, NJ, WI, FL, NH, IL, NY, IN, CA, AL, VA, MO, MI, KY, MA, PA, CO, ME, TN, WA, MN, SD, LA, NC, and NV and the country of Canada.

SoftLab with SA HIS versions 4.0.7.0-4.0.7.1 || SoftLab is a laboratory information system to be used in a medical research or clinical laboratory.

SoftMic GUI versions: 4.0.3.0-4.0.3.15, 4.0.4.1-4.0.4.7.

Clinical Chemistry and Clinical Toxicology Devices

1

No

Worldwide Distribution -- USA (nationwide) and Canada.

SoftMic GUI versions: 4.0.3.0-4.0.3.15, 4.0.4.1-4.0.4.7. || SoftMic is a laboratory information system to be used in medical research, clinical, and public health laboratories by knowledgeable, trained, and experienced personnel. SoftMic enables the user to handle data processing and laboratory activities for microbiology and serology testing, for the purpose of storing, managing, querying, and reporting laboratory data.

Versions 4.0.4.7, 4.5.1.3.

General Hospital and Personal Use Devices

Unclassified

No

Worldwide Distribution: USA, including the states of CA, CT, DE, FL, IA, KY, MA, MA, MI, MN, NJ, NY, OH, PA, TX, VA, and WI, and the country of Canada.

SoftMic Versions 4.0.4.7, 4.5.1.3. || Version 4.0.4.7 Manufactured 02/03/2010. || Version 4.5.1.3 Manufactured 03/18/2010. || SCC Soft Computer 5400 Tech Data Drive Clearwater, FL 33760.

Version 4.3.0.8 Release date: 07/31/2009 - Present;  Version 4.3.0.9 Release date: 11/23/2009 - Present;  Version 4.3.0.10 Release date: 09/20/2010- Present;  Version 4.3.0.11 Release date: 11/11/2010- Present;  Version 4.3.0.12 Release date: 02/07/2011- Present; Version 4.3.0.14 Release date: 11/14/2012- Present;  Version 4.3.0.15 Release date: 09/17/2013- Present;  Version 4.4.0.1 Release date: 12/13/2013 - Present;

Clinical Chemistry and Clinical Toxicology Devices

1

No

Distribution US Nationwide and CANADA.

SoftPath Laboratory Information System. Versions 4.3.0.8, 4.3.0.9, 4.3.0.10, 4.3.0.11, 4.3.0.12, 4.3.0.14, 4.3.0.15, and 4.4.0.0

Version 1.2, 2.1, 2.2 and 2.3

Clinical Chemistry and Clinical Toxicology Devices

1

No

Distributed to 106 consignees located throughout the United States and Canada.

Product is SoftPath ASCII Software Releases 1.2, 2.1, 2.2, and 2.3.

SoftPath GUI versions: 4.2.3.3-4.2.3.6 and 4.3.0.5-4.3.0.12.

Clinical Chemistry and Clinical Toxicology Devices

1

No

Worldwide Distribution-USA (nationwide) and the country of Canada.

SoftPath GUI versions: 4.2.3.3-4.2.3.6 and 4.3.0.5-4.3.0.12. || SoftPath is a laboratory information system to be used in a clinical laboratory by knowledgeable, trained, and experienced personnel. SoftPath enables the user to document steps in the receiving and processing of surgical, gynecological, medical cytological, and autopsy case specimens within the Pathology labs, for the purpose of generating Pathology reports for requesting physicians and label creation for identification of specimen/case material.

SoftPath GUI versions: 3.17.5 to 3.17.9, 4.2.1 to 4.2.3, and 4.3.0 to 4.3.0.4.

Clinical Chemistry and Clinical Toxicology Devices

1

No

Worldwide distribution: USA (nationwide) including states of: AR, AL, AZ, CA, CT, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MO, MN, NH, NJ, NY, OH, OK, PA, SD, TX, VA, WA, WI, WV including Puerto Rico; country of Canada.

SoftPath GUI versions: 3.17.5 to 3.17.9, 4.2.1 to 4.2.3, and 4.3.0 to 4.3.0.4. || SoftPath is a laboratory information system to be used in a clinical laboratory by knowledgeable, trained, and experienced personnel. SoftPath enables the user to document steps in the receiving and processing of surgical, gynecological, medical cytological, and autopsy case specimens within the Pathology labs, for the purpose of generating Pathology reports for requesting physicians and label creation for identification of specimen/case material.

Versions 3.17.5, 3.17.6, 3.17.7, 3.17.8, 4.1.0, and 4.1.1.

General Hospital and Personal Use Devices

Unclassified

No

Nationwide - USA, including the states of CA, CO, CT, FL, GA, IL, IN, LA, MD, MI, MO, MS, NC, NH, NJ, NV, NY, OH, OK, PA, SD, TX, WI, and WV

SoftPath GUI Releases 3.17 through 4.1.0. || SCC Soft Computer 5400 Tech Data Drive Clearwater, FL 33760. || Manufacture/Distribution Dates: || Version 3.17.5 10/14/2003. || Version 3.17.6 03/28/2003. || Version 3.17.7 07/02/2003. || Version 3.17.8 03/03/2004. || Version 4.1.0 07/03/2003. || Version 4.1.1 10/03/2003. || Intended for use in the Pathology Lab for receiving and accessioning specimens, documenting tissue processing, producing material labels, generating final diagnostic reports, and creating billing and management reports for surgical, GYN, NON-GYN, and Autopsy cases.

Versions 3.17 and 4.1

Clinical Chemistry and Clinical Toxicology Devices

1

No

Worldwide Distribution including USA and the country of Canada.

SoftPath GUI Release Software Versions 3.17 and 4.1. Used in pathology laboratory for receiving accessing specimen reports, billing and management reports for surgical, GYN, NON-GYN and Autopsy cases.

Version 3.17.6.3.1.

General Hospital and Personal Use Devices

Unclassified

No

Nationwide distribution: One hospital in NY.

SoftPath GUI version 3.17.6.3.1. || SCC Soft Computer 34350 US Highway 19 N, Palm Harbor, FL 34684. || Date of Manufacture: || Version 3.17.6.3.1 06/03/2003.

Version 3.17.7.6

General Hospital and Personal Use Devices

Unclassified

No

Nationwide Distribution to the states of IN, NC, NH, and NJ.

SoftPath GUI Versions 3.17 and 4.1. || SCC Soft Computer 5400 Tech Data Drive, Clearwater, FL 33760. || Manufactured: Version 3.17.7.6 10/23/2003

SoftPath GUI versions 4.2.3.4, 4.2.4.1, 4.3.0.3, 4.3.0.4.

General Hospital and Personal Use Devices

Unclassified

No

Worldwide Distribution: Throughout USA and Canada.

SoftPath GUI version 4.2.3.4 2008-06-30 (Manuf Date). || SoftPath GUI version 4.2.4.1 2008-09-30 (Manuf Date). || SoftPath GUI version 4.3.0.3, 2008-07-23 (Manuf Date). || SoftPath GUI version 4.3.0.4 2008-09-16 (Manuf Date). || SCC Soft Computer, 5400 Tech Data Drive, Clearwater, FL 33760.

SoftPath GUI Versions: 4.3.0.10, 4.3.0.11, and 4.3.0.12.

General Hospital and Personal Use Devices

Unclassified

No

Class II Recall - Worldwide Distribution -- USA (nationwide) and the country of Canada.

SoftPath GUI Versions: 4.3.0.10, 4.3.0.11, and 4.3.0.12. || SoftPath is a laboratory information system to be used in a clinical laboratory by knowledgeable, trained, and experienced personnel. SoftPath enables the user to document steps in the receiving and processing of surgical, gynecological, medical cytological, and autopsy case specimens within the Pathology labs, for the purpose of generating Pathology reports for requesting physicians and label creation for identification of specimen/case material.

Versions 2.2.0.6.3 and 2.2.0.7.1.

General Hospital and Personal Use Devices

Unclassified

No

Nationwide Distribution: including states of GA, LA, and NH.

Soft Query Results Reporting Versions 2.2.0.6.3 and 2.2.0.7.1. || SCC Soft Computer, 5400 Tech Data Drive, Clearwater, FL 33760. || Soft Query Results Reporting version 2.2.0.6.3 was released for General Availability on 09/11/03. || Soft Query Results Reporting version 2.2.0.7.1 was released for General Availability on 01/08/04.

Versions 1.1.6.x and 1.1.7.x.

General Hospital and Personal Use Devices

Unclassified

No

Worldwide Distribution--USA (nationwide) and the country of Canada.

SoftReports versions 1.1.6.x and 1.1.7.x || SoftReports version 1.1.6 released 2/2008; Version 1.1.7 released 6/2008. || SCC Soft Computer 5400 Tech Data Drive Clearwater, FL 33760. || SoftReports is a report designer and web-based report launching tool to be used by knowledgeable, trained, and experienced personnel. It provides the ability to create ad hoc, user defined queries, and reports using data from other SCC products. SoftReports enables users to customize standard reports generated by SCC systems to meet their specific needs. This system performs the following functions: 1. The ability to customize report layouts using beginner, intermediate, or advanced options. 2. The ability to import and export reports. 3. The ability to provide custom desktops to launch SQL's within other SCC applications. 4. The ability to preview and modify layouts specific to users' needs. 5. The ability to modify elements of reports using the comprehensive control formatting toolbar. 6. The ability to incorporate charts and graphics into reports. 7. The ability to modify existing query templates. 8. The ability to create independent and embedded queries. 9. The ability to pars SQL statements and notify users of errors within the syntax. 10. The ability to easily update criteria parameters to indicate input needed for executing queries. 11. The ability to view and print any report that is created using the Designer. 12. The ability to schedule, execute, and track ad-hoc reports. This system does not perform the following functions: 1. SoftReports is not configured to write back to the database. 2. SoftReports does not support user-created Ad Hoc reports being used for diagnostic purposes. 3. SoftReports is not intended to alter the meaning of patient result reports (test reports).