FDA 510(k) Applications Submitted by CARRI GRAHAM
FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
K050192 |
01/27/2005 |
BRC SOFTWARE PRODUCT |
BRC OPERATIONS PTY LIMITED |
K050326 |
02/09/2005 |
7350 ULTRASOUND IMAGING SYSTEM, MODEL 7350 |
ESAOTE, S.P.A. |
K040596 |
03/08/2004 |
ULTRASOUND IMAGING SYSTEM, MODEL 7300 |
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. |
K070903 |
04/02/2007 |
MYLAB40 |
ESAOTE EUROPE B.V. |
K080968 |
04/04/2008 |
S-SCAN, G-SCAN, DYNAMIC MRI SOFTWARE FOR C-SCAN, E-SCANXQ & E-SCAN OPERA |
ESAOTE S.P.A. |
K040877 |
04/05/2004 |
ARTOSCAN C |
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. |
K041145 |
05/03/2004 |
MODIFICATION TO E-SCAN XQ MRI SYSTEM |
ESAOTE S.P.A. |
K041198 |
05/07/2004 |
NIC36 AMPLIFIER |
EB NEURO, S.P.A. |
K051308 |
05/19/2005 |
MYLAB 70 ULTRASOUND IMAGING SYSTEM |
ESAOTE, S.P.A. |
K081393 |
05/19/2008 |
ORTHODONTIC TEMPORARY ANCHORAGE IMPLANT SCREW |
G & H WIRE CO. |
K061429 |
05/23/2006 |
DYNAMIC MRI SOFTWARE OPTION FOR C-SCAN, E-SCAN XQ AND E-SCAN OPERA |
ESAOTE, S.P.A. |
K041675 |
06/21/2004 |
PICUS, PARUS, FALCO AND AQUILA ULTRASOUND SYSTEMS |
PIE MEDICAL |
K061755 |
06/21/2006 |
MYLAB15/20 NEW INDICATIONS ULTRASOUND SYSTEM |
ESAOTE EUROPE B.V. |
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. |
K061961 |
07/11/2006 |
ART LAB SOFTWARE |
PIE MEDICAL |
K061996 |
07/14/2006 |
SANDMAN POCKET |
EB NEURO, 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. |
K062598 |
09/01/2006 |
IMT.LAB SOFTWARE |
ESAOTE EUROPE B.V. |
K052805 |
10/04/2005 |
MYLAB30, 50 AND 70 SYSTEMS UPGRADE, MODELS 7300, 7350, 6150 |
ESAOTE S.P.A. |
K063207 |
10/23/2006 |
S-SCAN MRI SYSTEM |
ESAOTE, S.P.A. |
K053154 |
11/14/2005 |
MYLAB15/20 3D/4D ULTRASOUND IMAGING SYSTEM |
PIE MEDICAL |
K043360 |
12/07/2004 |
IMT.LAB |
PIE MEDICAL |
K053606 |
12/27/2005 |
BE PLUS / AURA-LTM64 AMPLIFIER |
EB NEURO, S.P.A. |
K043588 |
12/28/2004 |
MYLAB 15 / MYLAB 20, MODEL 2700 |
PIE MEDICAL |
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