General Electric Co.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
256
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K110798SENOGRAPHE DS, SENOGRAPHE ESSENTIALDecember 22, 2011
K103485SENOGRAPH DS, SENOGRAPH ESSENSTIALOctober 6, 2011
K103489GE VEO RECONSTRUCTION OPTIONSeptember 9, 2011
K082317GE LUNAR FRAX 10-YEAR FRACTURE RISK SOFTWARE OPTIONSeptember 26, 2008
K081921GE VIVID E9 ULTRASOUNDAugust 6, 2008
K073297GE LOGIQ P6December 18, 2007
K072952GE ECHOPACNovember 16, 2007
K072797GE LOGIQ I COMAPACT ULTRASOUND, GE LOGIQ E COMPACT ULTRASOUND, GE VIVID E COMPACT ULTRASOUNDOctober 17, 2007
K072075MODIFICATION TO GE LOGIQ A3August 29, 2007
K071985GE VIVID S5 AND S6 DIAGNOSTIC ULTRASOUNDAugust 17, 2007
K063006GE LOGIQ WORKSNovember 2, 2006
K061682GE VOLUSON E8 ULTRASOUND SYSTEMJuly 12, 2006
K061525GE VIVID - IJuly 3, 2006
K061129GE LOGIQ 9, MODELS 2188900, 2375600, 2404587 AND 5150000June 1, 2006
K060993GE LOGIQ P5 AND A5May 3, 2006
K060542GE VIVID 7 MODEL FC008XX, GE VIVID 7 MODEL FC009XXMarch 31, 2006
K053435GE VOLUSON IDecember 16, 2005
K052441GE LOGIQ 7 ULTRASOUND BT05September 21, 2005
K050943GE VIEWPOINTMay 23, 2005
K050704MODIFICATION TO: REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH IMAGE PASTING AND AUTOPOSApril 8, 2005