Company
General Electric Med Systems LLC
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)
42recalls (0 in 12 months)
40recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | 10 |
| IZH | System, X-Ray, Mammographic | 7 |
| IZI | System, X-Ray, Angiographic | 5 |
| EAM | Screen, Intensifying, Radiographic | 4 |
| KPR | System, X-Ray, Stationary | 3 |
| KPS | System, Tomography, Computed, Emission | 3 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 2 |
| IYX | Camera, Scintillation (Gamma) | 2 |
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | 2 |
| 90L | 1 | |
| IXR | Table, Radiographic, Tilting | 1 |
| IYB | Tube Mount, X-Ray, Diagnostic | 1 |
| LLZ | System, Image Processing, Radiological | 1 |
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) |
|---|---|---|---|
| Jun 8, 2012 | General Electric Med Systems LLC GE Proteus XR/a Radiographic System. GE Medical Systems-Americas Milwaukee, WI.
Model Number: 2259988.
Product is indicated for use in generating radiographic images of human anatomy in all general- Terminated |
KPR | K993090 |
| Jun 8, 2012 | General Electric Med Systems LLC GE Healthcare Definium 8000 Digital Radiographic Systems :
GE Healthcare, 3000 North Grandview , Waukesha, WI, 53188
Model Number: 5131070.
The Revolution XR/d with Tomosynthesis is intended for use Terminated |
MQB | K012389 |
| Jun 8, 2012 | General Electric Med Systems LLC GE Healthcare Revolution XR/d; GE Healthcare, 3000 North Grandview , Waukesha, WI, 53188
Model numbers: 2259988-2 & 2351505.
The Revolution XR/d Digital Radiographic Imaging System is indicated for u Terminated |
MQB | K051967 |
| Sep 25, 2007 | General Electric Med Systems LLC GE Healthcare Proteus XR/a General Purpose Radiographic System, Models 2259973-4 and 2380179 containing Proteus Operator Console model# 2259976. Terminated |
KPR | K993090 |
| Jul 10, 2007 | General Electric Med Systems LLC GE Healthcare Innova 3100/ 3100 IQ Digital Fluoroscopic Imaging System (Cardiovascular Imaging System) Terminated |
MQB | K023178 K031637 +4 |
| Jul 10, 2007 | General Electric Med Systems LLC GE Healthcare Innova 2100 IQ Digital Fluoroscopic Imaging System (Versatile cardiac and vascular). Terminated |
MQB | K023178 K031637 +4 |
| Jun 28, 2007 | General Electric Med Systems LLC Diamond Mammographic X-Ray System, type MGX-2000, model 5111771. GE Healthcare P.O. Box 414, Milwaukee, Wisconsin 53201 U.S.A. Terminated |
IZH | K000976 |
| Jun 9, 2007 | General Electric Med Systems LLC GE Healthcare Innova 4100/ 4100 IQ Digital Fluoroscopic Imaging System (Vascular Angiography System). Terminated |
MQB | K023178 |
| Jun 9, 2007 | General Electric Med Systems LLC GE Healthcare Innova 3100/3100 IQ Digital Fluoroscopic Imaging system ( Cardiovascular Imaging System). Terminated |
MQB | K031637 |
| Jun 9, 2007 | General Electric Med Systems LLC GE Healthcare Innova 2100 IQ Digital Fluoroscopic Imaging System (Versatile cardiac and vascular imaging system.). Terminated |
MQB | K052412 |
| Jun 5, 2007 | General Electric Med Systems LLC GE Healthcare Innova 2100 IQ Digital Fluoroscopic Imaging System (Versatile cardiac and vascular) Terminated |
MQB | K023178 K031637 +4 |
| Jun 5, 2007 | General Electric Med Systems LLC GE Healthcare Innova 3100/ 3100 IQ Digital Fluoroscopic Imaging System (Cardiovascular Imaging System) Terminated |
MQB | K023178 K031637 +4 |
| Jun 5, 2007 | General Electric Med Systems LLC GE Healthcare Innova 4100/4100 IQ. Digital Fluoroscopic Imaging System (Vascular Angiography System) Terminated |
MQB | K023178 K031637 +4 |
| Sep 22, 2006 | General Electric Med Systems LLC GE Precision 500D Radiographic and Fluoroscopic Imaging System, Stationary X-ray System consisting of an X-ray generator; angulating table with x-ray Tube, collimator and image intensifier; wall stand Terminated |
JAA | K011624 |
| Jun 2, 2006 | General Electric Med Systems LLC Discovery ST PET/CT imaging system with gantry model number 5105797. Catalog Identifiers: S9114LA/LB/MA/MN, S9118LA/LB/MA/MN, S9116LA/MA. The system combines the high performance Lightspeed Plus CT Terminated |
KPS | K042257 |
| May 9, 2006 | General Electric Med Systems LLC Advantage CT/PET Fusion for Advantage Windows Workstation with Volume View CT Colonography/Navigator 2 software. (Version 4.0, 4.1,or 4.2) Terminated |
LLZ | K010336 |
| Feb 14, 2006 | General Electric Med Systems LLC Precision 500D Radiographic/Fluoroscopic X-ray System, model numbers 2225849, 005853. The Precision 500D system consists of an X-ray generator; angulating table with X-ray Tube, collimator and image Terminated |
JAA | K011624 |
| Feb 14, 2006 | General Electric Med Systems LLC Proteus XR/a Radiographic X-ray System, models 2259973-1, 2259973-2, 2259973-3, 2259973-4. The system consists of a radiographic table, a overhead tube suspension, high frequency generator and power Terminated |
KPR | K993090 |
| Jan 11, 2006 | General Electric Med Systems LLC LOCIQ Book System models: 2399921, 2399923, 2349933, 2349934 and 2349935 Terminated |
IYN | K014206 |
| Jan 11, 2006 | General Electric Med Systems LLC LOGIQ 5 system models 2331752, 2331753, 2332750, 2353313 and 2355477. Terminated |
IYN | K014097 |
| Oct 28, 2005 | General Electric Med Systems LLC Sopha Medical Vision DST / DST-XL Digital vatiable angle Nuclear Imaging System Terminated |
KPS | K942837 |
| Feb 24, 2005 | General Electric Med Systems LLC Patient tables of CT systems with brand name: CT/e; CT/e Dual; CT/e Plus, CT/e Dual Plus; CT/e Lite; ProSpeed AI; ProSpeed AII; ProSpeed FI; ProSpeed FII; ProSpeed EII; CT HiSpeed Series. Terminated |
IXR | K021491 K944013 +3 |
| Oct 7, 2004 | General Electric Med Systems LLC Emission Computed Tomography System. Including Model numbers: 2200967, ASM001080, ASM001083, ASM001092, ASM001099, ASM000085, 10036800109, and Varicam. Terminated |
KPS | K953801 |
| Aug 24, 2004 | General Electric Med Systems SMV FX-80 Nuclear Camera Terminated |
IYX | K935273 |
| Aug 24, 2004 | General Electric Med Systems SMV FX-40 Nuclear Camera Terminated |
IYX | K935273 |
| Jul 20, 2004 | General Electric Med Systems Advantx 1 SC Model 36006617 Angiographic X-ray System Terminated |
IZI | K890348 |
| Jul 20, 2004 | General Electric Med Systems Advantx 1 LC2 Model 2105657 Angiographic X-ray System Terminated |
IZI | K890348 |
| Jul 20, 2004 | General Electric Med Systems Advantx 1 LC2 Model 45562281 Angiographic X-ray System Terminated |
IZI | K890348 |
| Jul 20, 2004 | General Electric Med Systems Advantx 1 LC1 Model 45258230 Angiographic X-ray System Terminated |
IZI | K890348 |
| Jul 20, 2004 | General Electric Med Systems GE Single 20 inch TV Monitor Suspension for XT Bridge, Model 46-240485P6, Catalog Number B2056EG Terminated |
EAM | K760466 K801320 |
| Jul 20, 2004 | General Electric Med Systems GE Single 20 inch TV Monitor Suspension with Rail, Model 46-240485P5, Catalog Number B2056EC Terminated |
EAM | K760466 K801320 |
| Jul 20, 2004 | General Electric Med Systems GE Single 15 inch TV Monitor Suspension for XT Bridge, Model 46-240485P2, Catalog Number B2056HA Terminated |
EAM | K760466 K801320 |
| Jul 20, 2004 | General Electric Med Systems GE Single 15 inch TV Monitor Suspension with Rail, Model 46-240485P1, Catalog number B0256EH Terminated |
EAM | K760466 K801320 |
| Jul 20, 2004 | General Electric Med Systems Advantx 1 LC1 Model 46-279781P1 Angiographic X-ray System Terminated |
IZI | K890348 |
| Jul 20, 2004 | General Electric Med Systems Seneographe 600 Mammography X-Ray Systems (all versions) Terminated |
IZH | K881882 |
| Jul 20, 2004 | General Electric Med Systems Seneographe 500 Mammography X-Ray Systems (all versions) Terminated |
IZH | None listed |
| Jul 20, 2004 | General Electric Med Systems Seneographe 800T Mammography X-Ray Systems Terminated |
IZH | K953250 |
| Jul 20, 2004 | General Electric Med Systems Seneographe 700T Mammography X-Ray Systems Terminated |
IZH | K953250 |
| Jul 20, 2004 | General Electric Med Systems Seneographe DMR Mammography X-Ray System (all versions) Terminated |
IZH | K913418 |
| Jul 20, 2004 | General Electric Med Systems Seneographe 2000D Digital Mammography X-Ray System Terminated |
IZH | None listed |
| Jan 8, 2004 | General Electric Med Systems Performix X-ray Tube - Performix ADV, Performix Ultra, Solarix 630. Terminated |
IYB | K013561 K023988 |
| Feb 12, 2003 | General Electric Med Systems Revolution XR/d Wall Stand, Model Number 2291655, for Revolution XR/d Digital Radiographic Imaging Systems Terminated |
90L | K012389 |