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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