FDA 510(k) Applications Submitted by BOB LEIKER
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K090229 |
01/30/2009 |
DIAGNOSTIC DOPPLER ULTRASOUND SYSTEM 2-5MHZ CURVED LINEAR ARRAY, 5-10MHZ LINEAR ARRAY, 2-4MHZ PHASE ARRAY, 4-8MHZ TRANSV |
CHANG GUNG MEDICAL SUPPLIES & EQUIPMENT CORP. |
| K140364 |
02/12/2014 |
CHISON DIAGNOSTIC ULTRASOUND SYSTEM, CONVEX PROBE, LINEAR PROBE, PHASED AND CONVEX PROBE, PENCIL AND CONVEX PROBE |
CHISON MEDICAL IMAGING CO., LTD. |
| K120801 |
03/16/2012 |
CHISON DIAGNOSTIC ULTRASOUND SYSTEM |
CHISON MEDICAL IMAGING CO., LTD. |
| K990970 |
03/23/1999 |
SONOACE 6000C DIAGNOSTIC ULTRASOUND SYSTEM AND TRANSDUCERS, ALSO CALLED ULTRASOUND SYSTEM AND TRANSDUCERS |
MEDISON AMERICA, INC. |
| K070982 |
04/06/2007 |
CTS-7700 DIGITAL ULTRASOUND IMAGING SYSTEM |
SHANTOU INSTITUTE OF ULTRASONIC INSTUMENTS |
| K101008 |
04/12/2010 |
DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM, CONVEX ARRAY TRANSDUCER, LINEAR ARRAY |
SHANTOU I NSTITUTE OF ULTRASONIC INSTRUMENTS (SIUI |
| K061083 |
04/18/2006 |
CTS-7700 |
SHANTOU INSTITUTE OF ULTRASONIC INSTUMENTS |
| K081110 |
04/18/2008 |
SIUI CTS-900 DIGITAL ULTRASOUND IMAGING SYSTEM |
SHANTOU INSTITUTE OF ULTRASONIC INSTUMENTS |
| K131305 |
05/07/2013 |
CHISON DIAGNOSTIC ULTRASOUND SYSTEM, CONVEX PROBE, LINCAR PROBE, PHASED PROBE |
CHISON MEDICAL IMAGING CO., LTD. |
| K021497 |
05/09/2002 |
CYPRESS ULTRASOUND SYSTEM |
ACUSON CORP. |
| K061488 |
05/31/2006 |
CTS-5500/CTS-6600 ULTRASONIC PULSED ECHO IMAGING SYSTEM |
SHANTOU I NSTITUTE OF ULTRASONIC INSTRUMENTS (SIUI |
| K041455 |
06/01/2004 |
SSI-600/SSI-800 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM |
SONOSCAPE COMPANY LIMITED |
| K982013 |
06/08/1998 |
MGB LAPALUX TELESCOPE |
MGB ENDOSKOPISCHE GERATE GMBH |
| K091877 |
06/23/2009 |
CHISON DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM, CONVEX PROBE, LINEAR PROBE, PHASED ARRAY PROBE, TRANSVAGINAL |
CHISON MEDICAL IMAGING CO., LTD. |
| K121983 |
07/06/2012 |
DIAGNOSTIC DOPPLER ULTRASOUND SYSTEM CURVED LINEAR ARRAY 2-5 MHZ TRANSDUCER LINEAR ARRAY 5-11 MHZ TRANSDUCER PHASE ARRA |
BENQ MEDICAL TECHNOLOGY CORPATION |
| K102023 |
07/19/2010 |
DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM, MODEL APOGEE 3500, CONVEX ARRAY TRANSDUCER, MODEL C3L60C |
SHANTOU I NSTITUTE OF ULTRASONIC INSTRUMENTS (SIUI |
| K052042 |
07/28/2005 |
SONOSCAPE SSI-1000/SSI-5000 ULTRASOUND TRANSDUCERS |
SONOSCAPE COMPANY LIMITED |
| K132690 |
08/28/2013 |
UP600 DIAGNOSTIC DOPPLER ULTRASOUND SYSTEM |
QISDA CORPORATION |
| K042369 |
08/31/2004 |
SONOSCAPE ULTRASOUND SYSTEM SSI-1000/SSI-5000 |
SONOSCAPE COMPANY LIMITED |
| K112539 |
09/01/2011 |
CHISON DIGITAL ULTRASOUND SYSTEM, CONVEX PROBE, LINEAR PROBE, TRANSVAGINAL MICRO-CONVEX PROBE, TRANSRECTAL LINEAR PROBE |
LEIKER REGULATORY & QUALITY CONSULTING |
| K022896 |
09/03/2002 |
CSV12 SOFTWARE VIEWER |
ACUSON CORP. |
| K092907 |
09/22/2009 |
DIGITAL ULTRASOUND IMAGING SYSTEM, CONVEX ARRAY TRANSDUCER, LINEAR ARRAY TRANSDUCER, CONVEX ARRAY TRANSDUCER, PHASED ARR |
SHANTOU INSTITUTE OF ULTRASONIC INSTUMENTS |
| K092922 |
09/23/2009 |
SSI-8000/S8/S6 DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM, 2P1 PHASED ARRAY DIAGNOSTIC ULTRASOUND TRANSDUCER |
SONOSCAPE COMPANY LIMITED |
| K013327 |
10/05/2001 |
CTS-415 |
SHANTOU INSTITUTE OF ULTRASONIC INSTUMENTS |
| K102989 |
10/06/2010 |
OPUS DIAGNOSTIC ULTRASOUND SYSTEM & TRANSDUCERS |
CHANG GUNG MEDICAL TECHNOLOGY CO., LTD. LINKOU FAC |
| K103144 |
10/25/2010 |
DIGITAL COLOR DOPPLER ULTRASOUND IMAGAING SYSTEM; CONVEX / LINEAR PHASED ARRAY TRANSDUCER |
SHANTOU I NSTITUTE OF ULTRASONIC INSTRUMENTS (SIUI |
| K023772 |
11/12/2002 |
KINETDX PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM |
ACUSON CORP. |
| K113359 |
11/14/2011 |
CHISON DIAGNOSTIC ULTRASOUND SYSTEM,CONVEX PROBE,LINEAR PROBE,TRANSVAGINAL MICRO-CONVEX PROBE |
CHISON MEDICAL IMAGING CO., LTD. |
| K974813 |
12/23/1997 |
COMBISON 530D WITH POWER DOPPLER MODE |
MEDISON AMERICA, INC. |
| K984639 |
12/31/1998 |
THE S-VNA 5-8(B) DIAGNOSTIC ULTRASOUND TRANSDUCER |
MEDISON AMERICA, INC. |
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