SoftReports version 1.1.8.2.4 with Hot Fixes 1.7199.7 or 1.7200.7.

General Hospital and Personal Use Devices

Unclassified

No

Nationwide Distribution.

SoftReports version 1.1.8.2.4 with Hot Fixes 1.7199.7 or 1.7200.7. || SoftReports is a web-based report launching tool to be used in a hospital or laboratory environment by knowledgeable, trained, and experienced personnel. SoftReports enables the user to schedule and generate reports for the purpose of viewing and printing data stored in SCC product databases.

Model Catalog: V. 4.3.0.11 (Lot serial: ); Model Catalog: V. 4.3.0.12 (Lot serial: ); Model Catalog: VERSIONS 4.3.0.10 (Lot serial: )

SoftPath GUI v. 4.3.0.10-11-12

Model Catalog: V.4.3.0.12 (Lot serial: N/A); Model Catalog: V.4.3.0.15 (Lot serial: N/A); Model Catalog: V.4.3.0.14 (Lot serial: N/A); Model Catalog: V.4.4.0.1 (Lot serial: N/A)

SoftPath GUI Software

Model Catalog: SOFTPATH GUI VERSIONS 4.2.3.3 TO 4.2.3.6 (Lot serial: ); Model Catalog: SOFTPATH GUI VERSIONS 4.3.0.5 TO 4.3.0.12 (Lot serial: )

SoftPath GUI versions 4.2.3.3 to 4.2.3.6 and 4.3.0.5 to 4.3.0.12

Model Catalog: SOFTPATH GUI VERSIONS 4.2.1 TO 4.2.3 (Lot serial: ); Model Catalog: SOFTPATH GUI VERSIONS 3.17.5 TO 3.17.9 (Lot serial: ); Model Catalog: SOFTPATH GUI VERSIONS 4.3.0 TO 4.3.0.4 (Lot serial: )

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

Model Catalog: GUI VERSION 4.3.0.4 (Lot serial: ); Model Catalog: GUI VERSION 4.2.3.4 (Lot serial: ); Model Catalog: GUI VERSION 4.2.4.1 (Lot serial: ); Model Catalog: GUI VERSION 4.3.0.3 (Lot serial: )

SoftPath GUI v. 4.2.3.44.2.4.14.3.0.4

Model Catalog: (Lot serial: )

SOFTPATH ASCII RELEASES 2.3.0 & 4.3.7

SoftLab version 4.01 ASCII, ASCII Base 3.1.3.0-3.1.3.32, 3.1.4-3.1.4.27, 3.1.6-3.1.6.4, 4.0.0.0-4.0.0.9; LAB/MIC Add-on 4.0.1, 4.0.1.0-4.0.1.13, 4.0.2.0 in 2006.

General Hospital and Personal Use Devices

Unclassified

No

Nationwide Distribution: USA in the states of AL, AR, CA, CT, FL, GA, IA, IL, IN, KS, KY, LA, MD, ME, MI, MO, MS, NC, ND, NH, NJ, NY, OH, OK, PA, SD, TN, TX, VA, WA, WI, and WV.

SoftLab version 4.01 ASCII, ASCII Base 3.1.3.0-3.1.3.32, 3.1.4-3.1.4.27, 3.1.6-3.1.6.4, 4.0.0.0-4.0.0.9; LAB/MIC Add-on 4.0.1, 4.0.1.0-4.0.1.13, 4.0.2.0 in 2006. || SCC Soft Computer, 5400 Tech Data Drive, Clearwater, FL 33760.

Versions: 4.0.1.0 - 4.0.1.16; 4.0.2.0 - 4.0.2.10; 4.0.3.0 - 4.0.3.13; and 4.0.4.0 - 4.0.4.5.

Clinical Chemistry and Clinical Toxicology Devices

1

No

Nationwide Distribution

SoftLab GUI Version 4.0.1.0 - 4.0.1.16, 4.0.2.0 - 4.0.2.10, 4.0.3.0 - 4.0.3.13, and 4.0.4.0 - 4.0.4.5. || SCC Soft Computer 5400 Tech Data Drive Clearwater, FL 33760. || Manufacture/Distribution Dates: || 4.0.1.0 - 08/06/04, || 4.0.1.4 - 10/18/04, || 4.0.1.5 - 01/18/04, || 4.0.1.6 - 12/15/04, || 4.0.1.7 - 01/10/05, || 4.0.1.8 - 03/29/05, || 4.0.1.9 - 05/06/05, || 4.0.1.13 - 01/25/06, || 4.0.1.14 - 03/26/07 || 4.0.1.15 - 05/02/07, || 4.0.1.16 - 08/22/08, || 4.0.2.0 - 04/08/05, || 4.0.2.1 - 08/13/08, || 4.0.2.2 - 06/06/05, || 4.0.2.3 - 09/19/05, || 4.0.2.4 - 09/19/05, || 4.0.2.5 - 09/19/05, || 4.0.2.7 - 02/13/06, || 4.0.2.8 - 12/12/06, || 4.0.2.9 - 02/20/08, || 04.2.10 - 08/13/08, || 4.0.3.2 - 05/17/06, || 4.0.3.3 - 09/18/06, || 4.0.3.4 - 09/27/06, || 4.0.3.5 - 11/29/06, || 4.0.3.6 - 06/22/07, || 4.0.3.7 - 03/28/07, || 4.0.3.8 - 06/22/07, || 4.0.3.9 - 08/03/07, || 4.0.3.10 - 08/24/07, || 4.0.3.11 - 09/24/07, || 4.0.3.12 - 03/07/08, || 4.0.3.13 - 06/13/08, || 4.0.4.2 - 02/22/08, || 4.0.4.3 - 05/22/08, || 4.0.4.4 - 07/28/08, || 4.0.4.5 - 05/04/09. || Intends to provide clients with an interface that links all clinical laboratory departments throughout the enterprise.

SA INST versions: 3.1.6.12, 4.0.1.26-4.0.1.32, 4.0.2.21-4.0.2.51, and 4.0.3.5-4.0.3.13.

Clinical Chemistry and Clinical Toxicology Devices

1

No

US Nationwide Distribution

SoftLab with SA INST versions: 3.1.6.12, 4.0.1.26-4.0.1.32, 4.0.2.21-4.0.2.51, and 4.0.3.5-4.0.3.13. || Product UsageSoftLab 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: SA BASE 3.1.4.x, 3.1.6.x and SA LabMic 4.0.0.x, 4.0.1.x, 4.0.2.x, 4.0.3.x, 4.0.4.x.

Clinical Chemistry and Clinical Toxicology Devices

1

No

Worldwide Distribution - USA ( nationwide) and Canada.

Software: SA BASE 3.1.4.x, 3.1.6.x and SA LabMic 4.0.0.x, 4.0.1.x, 4.0.2.x, 4.0.3.x, 4.0.4.x. || 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.

Model Catalog: (Lot serial: 23.2.0.x); Model Catalog: (Lot serial: 23.1.2.x); Model Catalog: (Lot serial: 25.0.0.x)

SoftBank II v.23.1.2.x 23.2.0.x25.0.0

Model Catalog: V.25.2 (Lot serial: V. 1.3.0.X); Model Catalog: V.25.3 (Lot serial: USED WITH SOFTSCAPE GUI); Model Catalog: V.23.1 (Lot serial: USED WITH SOFTSCAPE GUI); Model Catalog: V.23.2 (Lot serial: USED WITH SOFTSCAPE GUI); Model Catalog: V.25.0 (Lot serial: USED WITH SOFTSCAPE GUI); Model Catalog: V.25.1 (Lot serial: USED WITH SOFTSCAPE GUI); Model Catalog: V.25.2 (Lot serial: USED WITH SOFTSCAPE GUI); Model Catalog: V.25.3 (Lot serial: V. 1.2.0.X); Model Catalog: V.23.1 (Lot serial: V. 1.2.0.X); Model Catalog: V.23.2 (Lot serial: V. 1.2.0.X); Model Catalog: V.25.1 (Lot serial: V. 1.3.0.X); Model Catalog: V.25.0 (Lot serial: V. 1.3.0.X); Model Catalog: V.23.2 (Lot serial: V. 1.3.0.X); Model Catalog: V.23.1 (Lot serial: V. 1.3.0.X); Model Catalog: V.25.3 (Lot serial: V. 1.3.0.X); Model Catalog: V.25.2 (Lot serial: V. 1.2.0.X); Model Catalog: V.25.1 (Lot serial: V. 1.2.0.X); Model Catalog: V.25.0 (Lot serial: V. 1.2.0.X)

SOFTBANK II V.23.123.225.025.125.225.3

Model Catalog: V.25.1 (Lot serial: ALL LOT); Model Catalog: V.23.2 (Lot serial: ALL LOT); Model Catalog: V.25.0 (Lot serial: ALL LOT)

SOFTBANK II V.23.2/25.0/25.1

Model Catalog: V.23.2 (Lot serial: v. 1.3.0.4 - 1.3.0.5); Model Catalog: V.23.1 (Lot serial: v. 1.3.0.4 - 1.3.0.5); Model Catalog: V. 23.0 (Lot serial: v. 1.3.0.4 - 1.3.0.5); Model Catalog: V.25.1 (Lot serial: v. 1.2.0.7 - 1.2.0.15); Model Catalog: V.25.0 (Lot serial: v. 1.2.0.7 - 1.2.0.15); Model Catalog: V.23.2 (Lot serial: v. 1.2.0.7 - 1.2.0.15); Model Catalog: V.23.1 (Lot serial: v. 1.2.0.7 - 1.2.0.15); Model Catalog: V. 23.0 (Lot serial: v. 1.2.0.7 - 1.2.0.15); Model Catalog: V.25.1 (Lot serial: Used with SoftScape Gui); Model Catalog: V.25.0 (Lot serial: Used with SoftScape Gui); Model Catalog: V.23.2 (Lot serial: Used with SoftScape Gui); Model Catalog: V.23.1 (Lot serial: Used with SoftScape Gui); Model Catalog: V. 23.0 (Lot serial: Used with SoftScape Gui); Model Catalog: V.25.1 (Lot serial: v. 1.3.0.4 - 1.3.0.5); Model Catalog: V.25.0 (Lot serial: v. 1.3.0.4 - 1.3.0.5)

SoftBank II v.23.023.123.225.025.1

Version: 23.1.2, 23.2.0, 25.0.0, 25.1.0, 25.2.0, 25.3.0

General Hospital and Personal Use Devices

Unclassified

No

Worldwide Distribution - US Nationwide Distribution in the states of AL, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NH, NJ, NV, NY, OH, OK, OR, PA, RI, TN, TX, VA, WA, WI, WV, and the countries of Hawaii and Puerto Rico Canada & Jamaica

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.

Version: 35.5.2.0, 25.5.3.0, 25.5.3.1

General Hospital and Personal Use Devices

Unclassified

No

Worldwide Distribution - US Nationwide Distribution in the states of AL, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NH, NJ, NV, NY, OH, OK, OR, PA, RI, TN, TX, VA, WA, WI, WV, and the countries of Hawaii and Puerto Rico Canada & Jamaica

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.

Versions 4.0.2.38.1, 4.0.2.39.2, 4.02.40.1, and 4.0.2.41.1.

General Hospital and Personal Use Devices

Unclassified

No

Worldwide Distribution - USA, including AL, CO, FL, GA, IN, KS, KY, MA, MO, NC, NH, NJ, NY, OH, PA, TN, and WA and the country of Canada

Hospital Information System Results Reporting Interface Versions 4.0.2.38.1, 4.0.2.39.2, 4.02.40.1, and 4.0.2.41.1. || SCC Soft Computer, 5400 Tech Data Drive, Clearwater, FL 33760. || Manufacture Dates: || 4.0.2.38.1 06/15/07 || 4.02.39.2 06/29/07, || 4.02.40.1 07/19/07, || 4.02.41.1 08/20/07. || The Result Reporting Interface is a highly versatile interface designed to electronically convey clinical laboratory orders and results for the SCC applications to other recipient information systems.

version 4.0.4.10.1.

General Hospital and Personal Use Devices

Unclassified

No

Nationwide Distribution: 1 hospital in Alaska.

SoftWeb version 4.0.4.10.1. || SCC Soft Computer, 5400 Tech Data Drive, Clearwater, FL 33760. || Manufacture Date: 05/16/2006.

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).

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.

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.

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.

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

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.