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
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 9, 2015 | SCC 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 |
JQP | None listed |
| Feb 2, 2015 | SCC 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 |
JQP | None listed |
| May 9, 2014 | SCC 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 |
JQP | None listed |
| Aug 3, 2012 | SCC 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 |
JQP | None listed |
| Jan 11, 2012 | SCC 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 |
JQP | None listed |
| Jan 11, 2012 | SCC 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 |
JQP | None listed |
| Jan 11, 2012 | SCC 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 |
JQP | None listed |
| Dec 2, 2011 | SCC 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 |
JQP | None listed |
| Dec 2, 2011 | SCC 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 |
LNX | None listed |
| Dec 2, 2011 | SCC 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 |
LNX | None listed |
| Nov 23, 2011 | SCC 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 |
LNX | None listed |
| Nov 23, 2011 | SCC 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 |
LNX | None listed |
| Nov 21, 2011 | SCC 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 |
JQP | None listed |
| Nov 17, 2011 | SCC 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 |
JQP | None listed |
| Jun 30, 2011 | SCC 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 |
LNX | None listed |
| Nov 16, 2010 | SCC 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 |
JQP | None listed |
| Nov 15, 2010 | SCC 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 |
LNX | None listed |
| Nov 15, 2010 | SCC 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 |
MMH | None listed |
| Nov 15, 2010 | SCC 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 |
JQP | None listed |
| Nov 10, 2010 | SCC 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 |
JQP | None listed |
| Oct 20, 2010 | SCC 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 |
LNX | None listed |
| Oct 20, 2010 | SCC 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 |
LNX | None listed |
| Oct 20, 2010 | SCC 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 |
LNX | None listed |
| Oct 19, 2010 | SCC 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 |
LNX | None listed |
| Oct 19, 2010 | SCC 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 |
LNX | None listed |
| Oct 19, 2010 | SCC 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 |
LNX | None listed |
| Oct 18, 2010 | SCC 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 |
LNX | None listed |
| Oct 15, 2010 | SCC 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 |
LNX | None listed |
| Oct 15, 2010 | SCC 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 |
LNX | None listed |
| Sep 22, 2008 | SCC Soft Computer Product is SoftPath ASCII Software Releases 1.2, 2.1, 2.2, and 2.3. Terminated |
JQP | None listed |
| Sep 22, 2008 | SCC 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 |
JQP | None listed |
| Jul 27, 2006 | SCC 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 |
JQP | None listed |
| Jul 26, 2006 | SCC 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 |
JQP | None listed |