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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