FDA 510(k) Applications Submitted by NICOLE LANDREVILLE
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K180782 |
03/26/2018 |
Aria |
GE Medical Systems Ultrasound & Primary Care Diagnostics,LLC |
| K190809 |
03/29/2019 |
Sample Imaging for Senographe Pristina |
GE Healthcare |
| K981315 |
04/10/1998 |
NAVITRACK |
ORTHOSOFT, INC. |
| K061269 |
05/05/2006 |
XLTEK CLEAN SIGNAL ADHESIVE ELECTRODES |
EXCEL TECH. LTD. |
| K161682 |
06/17/2016 |
GE Lunar DXA Bone Densitometers with enCORE version 17 |
GE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE DIAGNOSTICS,LLC |
| K131977 |
06/28/2013 |
CENTRICITY UNIVERSAL VIEWER ZERO FOOTPRINT CLIENT |
GE HEALTHCARE |
| K002053 |
07/06/2000 |
NAVITRAK SYSTEM-OPTICAL OPTION, MODEL 900.004 |
ORTHOSOFT, INC. |
| K092271 |
07/28/2009 |
GE LOGIQ E9 BT2010 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL 5205000-3, 5205000-4 |
GE HEALTHCARE |
| K082185 |
08/01/2008 |
GE LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM, MODELS 5205000, 5205000-2 |
GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIA |
| K052111 |
08/04/2005 |
XLTEK CLEAR SIGNAL SUB-DERMAL NEEDLE, MODELS 102889, 102798, 102799, 102382 |
EXCEL TECH. LTD. |
| K052112 |
08/04/2005 |
XLTEK XCALIBUR EMG / LT, MODEL PK1P33, PK1059 |
EXCEL TECH. LTD. |
| K042150 |
08/09/2004 |
XLTEK TREX MODEL#10309 |
EXCEL TECH. LTD. |
| K042223 |
08/17/2004 |
XLTEK CONNEX IP HEADBOX, MODEL 1054 |
EXCEL TECH. LTD. |
| K092639 |
08/27/2009 |
INNOVA VISION, MODEL S18751VN, INNOVA TRACKVISION, MODEL S18751VT, INNOVA EPVISION, MODEL S18751EP |
GE MEDICAL SYSTEMS SCS |
| K062549 |
08/30/2006 |
XLTEK STIMULATOR PROBES, MODELS 105233, 105234, 105235, 105236, 105237 AND 105238 |
EXCEL TECH. LTD. |
| K182951 |
10/23/2018 |
Pristina Serena 3D |
GE Healthcare |
| K053058 |
10/31/2005 |
XLTEK NEUROPATH, MODEL PK1070 |
EXCEL TECH. LTD. |
| K103458 |
11/23/2010 |
VIEWPOINT 6 |
GE HEALTHCARE |
| K073408 |
12/04/2007 |
GE LOGIQ BT08 DIAGNOSTIC ULTRASOUND SYSTEM |
GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIA |
| K053386 |
12/05/2005 |
XLTEK EMU40 EEG HEADBOX, MODEL PK1072 |
EXCEL TECH. LTD. |
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