ClearanceBrief
Company

SCC Soft Computer

FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.

0510(k) clearances (0 in 12 months)
33recalls (0 in 12 months)
0recalls that name a 510(k)

Product codes

CodeDeviceRecords
JQPCalculator/Data Processing Module, For Clinical Use17
LNX15
MMHBlood Establishment Computer Software And Accessories1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
No clearances in this window.

Latest recalls

DateFirm and productCodeLinked 510(k)
Feb 9, 2015SCC Soft Computer
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
Terminated
JQPNone listed
Feb 2, 2015SCC Soft Computer
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.
Terminated
JQPNone listed
May 9, 2014SCC Soft Computer
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
Terminated
JQPNone listed
Aug 3, 2012SCC Soft Computer
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 clini
Terminated
JQPNone listed
Jan 11, 2012SCC Soft Computer
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,
Terminated
JQPNone listed
Jan 11, 2012SCC Soft Computer
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
Terminated
JQPNone listed
Jan 11, 2012SCC Soft Computer
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:
Terminated
JQPNone listed
Dec 2, 2011SCC Soft Computer
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. Soft
Terminated
JQPNone listed
Dec 2, 2011SCC Soft Computer
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. SoftPat
Terminated
LNXNone listed
Dec 2, 2011SCC Soft Computer
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
Terminated
LNXNone listed
Nov 23, 2011SCC Soft Computer
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, t
Terminated
LNXNone listed
Nov 23, 2011SCC Soft Computer
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.
Terminated
LNXNone listed
Nov 21, 2011SCC Soft Computer
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
Terminated
JQPNone listed
Nov 17, 2011SCC Soft Computer
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 experien
Terminated
JQPNone listed
Jun 30, 2011SCC Soft Computer
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 repo
Terminated
LNXNone listed
Nov 16, 2010SCC Soft Computer
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:
Terminated
JQPNone listed
Nov 15, 2010SCC Soft Computer
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
Terminated
LNXNone listed
Nov 15, 2010SCC Soft Computer
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 app
Terminated
MMHNone listed
Nov 15, 2010SCC Soft Computer
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 labo
Terminated
JQPNone listed
Nov 10, 2010SCC Soft Computer
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
Terminated
JQPNone listed
Oct 20, 2010SCC Soft Computer
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 D
Terminated
LNXNone listed
Oct 20, 2010SCC Soft Computer
SoftWeb version 4.0.4.10.1. SCC Soft Computer, 5400 Tech Data Drive, Clearwater, FL 33760. Manufacture Date: 05/16/2006.
Terminated
LNXNone listed
Oct 20, 2010SCC Soft Computer
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
Terminated
LNXNone listed
Oct 19, 2010SCC Soft Computer
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.
Terminated
LNXNone listed
Oct 19, 2010SCC Soft Computer
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.
Terminated
LNXNone listed
Oct 19, 2010SCC Soft Computer
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
Terminated
LNXNone listed
Oct 18, 2010SCC Soft Computer
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 A
Terminated
LNXNone listed
Oct 15, 2010SCC Soft Computer
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
Terminated
LNXNone listed
Oct 15, 2010SCC Soft Computer
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. Versi
Terminated
LNXNone listed
Sep 22, 2008SCC Soft Computer
Product is SoftPath ASCII Software Releases 1.2, 2.1, 2.2, and 2.3.
Terminated
JQPNone listed
Sep 22, 2008SCC Soft Computer
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
Terminated
JQPNone listed
Jul 27, 2006SCC Soft Computer
Product is SoftPath ASCII Software Releases 2.3.0 and 4.3.7. The software is used in pathology labs for administrative and clinicial documentation and data processing.
Terminated
JQPNone listed
Jul 26, 2006SCC Soft Computer
SoftPath ASCII Software, used in pathology labs to track and report specimens and diagnostic results. Releases 1.2, 2.1, and 2.3
Terminated
JQPNone listed
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