Company
General Electric Medical Systems Information Technology
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)
15recalls (0 in 12 months)
11recalls 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) |
|---|---|---|---|
| Jan 13, 2010 | General Electric Medical Systems Information Technology GE ApexPro Oximeter systems (ApexPro CH or ApexPro FH with ApexPro Telemetry version 3.9 software) Terminated |
DQA | K980299 |
| Feb 1, 2008 | General Electric Medical Systems Information Technology GE Healthcare CIC Pro Clinical Information Center, Central Station, Software Version 4.1. (CIC Pro v4.1). GE Medical Systems Information Technologies, Inc., Milwaukee, Wisconsin (System hardware con Terminated |
DSI | K032370 |
| Jan 17, 2008 | General Electric Medical Systems Information Technology GE Medical Systems Information Technologies Clinical Information Center (CIC) Pro v5.0.3 & v5.0.6 systems, GE Healthcare, Clinical Systems Terminated |
DSI | K062976 |
| Aug 7, 2007 | General Electric Medical Systems Information Technology GE Healthcare Systems ComboLab System. Made up of both
Mac-Lab System, Software Version 6.5 2021423-015 Revision D and CardioLab System, Software Version 6.5 2021423-016 Revision D. Electrophysiolog Terminated |
DQK | K050093 |
| Aug 7, 2007 | General Electric Medical Systems Information Technology GE Medical Systems CardioLab System, electrophysiological data system, Software Version 6.5 2021423-016 Revision D GE Medical Systems, Information Technologies, Inc. 8200 West Tower Avenue, Milwaukee, Terminated |
DQK | K050093 |
| Aug 7, 2007 | General Electric Medical Systems Information Technology GE Medical Systems Mac-Lab System, cardiac catheterization data system. Software Version 6.5 2021423-015 Revision D GE Medical Systems, Information Technologies, Inc., 8200 West Tower Avenue, Milwauk Terminated |
DQK | K050093 |
| Jun 6, 2007 | General Electric Medical Systems Information Technology GE Healthcare CIC Pro Clinical Information Center, Central Station, Software Version 4.1. , GE Medical Systems Information Technologies, Inc., 8200 W. Tower Ave. Milwaukee, Wisconsin USA. (System hard Terminated |
DSI | K032370 |
| Oct 21, 2004 | General Electric Medical Systems Information Technology GE CIC Central Station Monitoring Product, Versions 3.x, 4.0.5, 4.0.6 Terminated |
DSI | K032370 |
| Jul 20, 2004 | General Electric Medical Systems Information Technology PatientNet Monitoring System - PatientNet Central Stations utilizing software Versions 1.03.14, 1.04xx, 2.00xx. Terminated |
MSX | K020524 |
| Dec 18, 2003 | General Electric Medical Systems Information Technology Solar 9500 Information Monitor with software version 3A. Terminated |
MHX | K030575 |
| Nov 6, 2003 | General Electric Medical Systems Information Technology Solar 8000M Patient Monitor with software versions 3A, 3B and 3C Terminated |
DSI | None listed |
| Apr 25, 2003 | General Electric Medical Systems Information Technology MAC-LAB (Classic) systems Terminated |
KMI | None listed |
| Apr 25, 2003 | General Electric Medical Systems Information Technology MAC-LAB 5000EX systems Terminated |
KMI | None listed |
| Apr 25, 2003 | General Electric Medical Systems Information Technology MAC-LAB 3000EX systems Terminated |
KMI | None listed |
| Apr 25, 2003 | General Electric Medical Systems Information Technology MAC-LAB 1000EX systems Terminated |
KMI | K021366 |