Company ยท US
General Electric Co.
FDA 510(k) clearances and medical device recalls filed under this name, 1976 to 2011. Name variants (Inc, Corp, punctuation) are merged.
256510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JAK | System, X-Ray, Tomography, Computed | 31 |
| LNH | System, Nuclear Magnetic Resonance Imaging | 29 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 23 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 21 |
| IYX | Camera, Scintillation (Gamma) | 15 |
| IZO | Generator, High-Voltage, X-Ray, Diagnostic | 12 |
| ITX | Transducer, Ultrasonic, Diagnostic | 11 |
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | 10 |
| KPS | System, Tomography, Computed, Emission | 9 |
| KPR | System, X-Ray, Stationary | 5 |
| LLZ | System, Image Processing, Radiological | 5 |
| DSI | Detector And Alarm, Arrhythmia | 4 |
| HEM | Imager, Ultrasonic Obstetric-Gynecologic | 4 |
| IZI | System, X-Ray, Angiographic | 4 |
| IXR | Table, Radiographic, Tilting | 3 |
| IZZ | Table, Radiographic, Non-Tilting, Powered | 3 |
| JWM | System, Tomographic, Nuclear | 3 |
| DXG | Computer, Diagnostic, Pre-Programmed, Single-Function | 2 |
| EAP | Unit, X-Ray, Intraoral | 2 |
| EHD | Unit, X-Ray, Extraoral With Timer | 2 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 22, 2011 | K110798 | SENOGRAPHE DS, SENOGRAPHE ESSENTIAL General Electric Company | MUE |
| Oct 6, 2011 | K103485 | SENOGRAPH DS, SENOGRAPH ESSENSTIAL General Electric Company | MUE |
| Sep 9, 2011 | K103489 | GE VEO RECONSTRUCTION OPTION General Electric Co. | JAK |
| Sep 26, 2008 | K082317 | GE LUNAR FRAX 10-YEAR FRACTURE RISK SOFTWARE OPTION General Electric Co. | KGI |
| Aug 6, 2008 | K081921 | GE VIVID E9 ULTRASOUND General Electric Co. | IYN |
| Dec 18, 2007 | K073297 | GE LOGIQ P6 General Electric Co. | IYN |
| Nov 16, 2007 | K072952 | GE ECHOPAC General Electric Co. | LLZ |
| Oct 17, 2007 | K072797 | GE LOGIQ I COMAPACT ULTRASOUND, GE LOGIQ E COMPACT ULTRASOUND, GE VIVID E COMPACT ULTRASOUND General Electric Co. | IYO |
| Aug 29, 2007 | K072075 | MODIFICATION TO GE LOGIQ A3 General Electric Co. | IYN |
| Aug 17, 2007 | K071985 | GE VIVID S5 AND S6 DIAGNOSTIC ULTRASOUND General Electric Co. | IYN |
| Nov 2, 2006 | K063006 | GE LOGIQ WORKS General Electric Co. | LLZ |
| Jul 12, 2006 | K061682 | GE VOLUSON E8 ULTRASOUND SYSTEM General Electric Co. | IYO |
| Jul 3, 2006 | K061525 | GE VIVID - I General Electric Co. | IYN |
| Jun 1, 2006 | K061129 | GE LOGIQ 9, MODELS 2188900, 2375600, 2404587 AND 5150000 General Electric Co. | IYN |
| May 3, 2006 | K060993 | GE LOGIQ P5 AND A5 General Electric Co. | IYN |
| Mar 31, 2006 | K060542 | GE VIVID 7 MODEL FC008XX, GE VIVID 7 MODEL FC009XX General Electric Co. | IYN |
| Dec 16, 2005 | K053435 | GE VOLUSON I General Electric Co. | IYN |
| Sep 21, 2005 | K052441 | GE LOGIQ 7 ULTRASOUND BT05 General Electric Co. | IYN |
| May 23, 2005 | K050943 | GE VIEWPOINT General Electric Co. | LLZ |
| Apr 8, 2005 | K050704 | MODIFICATION TO: REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH IMAGE PASTING AND AUTOPOSITIONING General Electric Co. | KPR |
| Feb 2, 2005 | K050126 | GE LOGIQ TWIN General Electric Co. | IYN |
| Nov 24, 2004 | K043112 | GE 0.2T SIGNA PROFILE EXCITE MR SYSTEM General Electric Co. | LNH |
| Sep 8, 2004 | K042257 | DISCOVERY ST PET/CT IMAGING SYSTEM WITH AN ALTERNATE DETECTOR OPTION General Electric Co. | KPS |
| Jul 28, 2004 | K041922 | GE TETHERED PORTABLE DIGITAL RADIOGRAPHIC DETECTOR General Electric Co. | IZL |
| Jul 8, 2004 | K041688 | GE VOLUSON 730 PRO/EXPERT UNTRASOUND BT04 General Electric Co. | IYN |
| Jul 2, 2004 | K041552 | GE VIVID 7 BT04 General Electric Co. | IYN |
| Apr 14, 2004 | K040444 | GE SIGNA 3.0T WITH EXCITE MR SYSTEM General Electric Co. | LNH |
| Dec 19, 2003 | K033867 | GE BRAINWAVE OPTION(S) FOR MRI SYSTEMS General Electric Co. | LNH |
| Nov 25, 2003 | K033504 | GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM General Electric Co. | LNH |
| Oct 23, 2003 | K033139 | GE MARLIN ULTRASOUND General Electric Co. | IYN |
| Oct 22, 2003 | K032477 | GE LOGIQ BOOK General Electric Co. | IYN |
| Oct 21, 2003 | K032974 | GE LOGIQ 5 PRO OR EXPERT General Electric Co. | IYN |
| Oct 10, 2003 | K033168 | GE 0.2T SIGNA PROFILE/I MR SYSTEM General Electric Co. | LNH |
| Oct 10, 2003 | K032620 | GE VOLUSON 730 PRO/EXPERT BT03 ULTRASOUND SYSTEM General Electric Co. | IYN |
| Jul 25, 2003 | K032182 | GE LOGIQ 7, MODEL 2354858 General Electric Co. | IYN |
| Jun 9, 2003 | K031663 | GE VIVID 7, MODEL FC0003XX General Electric Co. | IYN |
| Mar 28, 2003 | K030874 | GE 3.0T SIGNA INFINITY TWINSPEED WITH EXCITE MR SYSTEM General Electric Co. | LNH |
| Feb 11, 2003 | K030199 | GE MOBILE DISCOVERY ST PET CT IMAGING SYSTEM General Electric Co. | KPS |
| Sep 12, 2002 | K022872 | GE ROAD WARRIOR PET CT IMAGING SYSTEM General Electric Co. | KPS |
| Apr 4, 2002 | K020789 | GE VIVID 3 EXPERT; GE VIVID 3 PRO General Electric Co. | IYN |
| Feb 6, 2002 | K020263 | LOGIQ 3 General Electric Co. | IYN |
| Jan 16, 2002 | K014206 | LOGIQBOOK General Electric Co. | IYO |
| Oct 26, 2001 | K013381 | ADVANCED LUNG ANALYSIS-1 General Electric Co. | JAK |
| Sep 6, 2001 | K012568 | GE VISION NUCLEAR MEDICINE WORKSTATION General Electric Co. | KPS |
| Aug 23, 2001 | K012560 | GE LOGIQ A100 MP, MODEL 2272413 General Electric Co. | IYO |
| Mar 1, 2001 | K010329 | LOGIQ 500 General Electric Co. | IYN |
| Jan 30, 2001 | K010042 | CT PERFUSION 2 General Electric Co. | JAK |
| Sep 22, 1999 | K993069 | GE DIASONICS GATEWAY AND GATEWAY FX General Electric Co. | IYO |
| Jun 9, 1999 | K991611 | GE LOGIQ 500 General Electric Co. | IYO |
| Aug 18, 1998 | K982004 | CT CORONARY ARTERY CALCIFICATION SCORING (CACS) OPTION FOR ADVANTAGE WINDOWS General Electric Co. | JAK |
Newest 50 of 256.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||