FDA 510(k) Applications Submitted by Esaote, S.p.A.

FDA 510(k) Number Submission Date Device Name Applicant
K100670 03/09/2010 S-SCAN, MODEL 9800020010 ESAOTE, S.P.A.
K100931 04/05/2010 MYLABTWICE, MODEL 6200 ESAOTE, S.P.A.
K111302 05/09/2011 MYLABSEVEN, MYLABALPHA ESAOTE, S.P.A.
K121650 06/05/2012 S-SCAN ESAOTE, S.P.A.
K111803 06/27/2011 G-SCAN ESAOTE, S.P.A.
K132231 07/18/2013 MYLABSEVEN, MYLABALPHA ESAOTE, S.P.A.
K142077 07/31/2014 MYLABGAMMA ESAOTE, S.P.A.
K103152 10/26/2010 6250 ULTRASOUND SYTEMS ESAOTE, S.P.A.
K120288 01/31/2012 ORTHOCAD SOFTWARE OPTION ESAOTE, S.P.A.
K120748 03/12/2012 SPEEDUP SOFTWARE OPTION ESAOTE, S.P.A.
K121384 05/08/2012 MYLABSOGNO ESAOTE, S.P.A.
K131996 06/28/2013 S-SCAN ESAOTE, S.P.A.
K122006 07/09/2012 G-SCAN BRIO ESAOTE, S.P.A.
K050326 02/09/2005 7350 ULTRASOUND IMAGING SYSTEM, MODEL 7350 ESAOTE, S.P.A.
K060827 03/27/2006 MYLAB30, 50, 70 AND 90 SYSTEMS ADDITION OF 3D/4D, MODELS 7300, 7350, 6150, 6100 ESAOTE, S.P.A.
K060956 04/07/2006 G-SCAN-MODEL 9800020000, E-SCAN MODEL 9800010000 AND E-SCAN XQ-MODELS-9800010011/9800010005,9800010009/9800010004 ESAOTE, S.P.A.
K051308 05/19/2005 MYLAB 70 ULTRASOUND IMAGING SYSTEM ESAOTE, S.P.A.
K061429 05/23/2006 DYNAMIC MRI SOFTWARE OPTION FOR C-SCAN, E-SCAN XQ AND E-SCAN OPERA ESAOTE, S.P.A.
K081794 06/25/2008 MODEL 7340 ULTRASOUND SYSTEM ESAOTE, S.P.A.
K051837 07/06/2005 MYLAB 90 ULTRASOUND IMAGING SYSTEM, MODEL 6100 ESAOTE, S.P.A.
K052077 08/01/2005 G-SCAN CERVICAL SPINE COIL ESAOTE, S.P.A.
K042236 08/18/2004 G-SCAN ESAOTE, S.P.A.
K063207 10/23/2006 S-SCAN MRI SYSTEM ESAOTE, S.P.A.
K142421 08/28/2014 G-scan Brio ESAOTE, S.P.A.
K183191 11/19/2018 6420 Ultrasound System Esaote, S.p.A.
K192157 08/09/2019 6450 Ultrasound system Esaote, S.p.A.
K190989 04/15/2019 6400 Ultrasound System (MyLabX6, MyLabX7) Esaote, S.p.A.


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