Medical Device Manufacturer · US , Fremont , CA

Medison America, Inc. - FDA 510(k) Cleared Devices

21 submissions · 21 cleared · Since 1993
21
Total
21
Cleared
0
Denied
FDA 510(k) Regulatory Record - Medison America, Inc. Radiology
21 devices
1-21 of 21
Cleared Aug 06, 2003
SA 9900 PLUS DIAGNOSTIC ULTRASOUND SYSTEM
K032329 · IYN
Radiology · 8d
Cleared May 30, 2003
MYCOLOR 202 DIAGNOSTIC ULTRASOUND SYSTEM AND TRANSDUCERS
K031552 · IYN
Radiology · 11d
Cleared Nov 16, 2001
SONOACE SA-8000 DIAGNOSTIC ULTRASOUND SYSTEM
K013627 · IYN
Radiology · 11d
Cleared Sep 12, 2001
SONOACE 9900 DIAGNOSTIC ULTRASOUND SYSTEM
K012867 · IYN
Radiology · 16d
Cleared Sep 12, 2001
SA6000II DIAGNOSTIC ULTRASOUND SYSTEM
K012887 · IYO
Radiology · 15d
Cleared Nov 22, 2000
VOLUSON 730 DIAGNOSTIC ULTRASOUND SYSTEM
K003525 · IYN
Radiology · 7d
Cleared Oct 20, 2000
MYSONO 201 DIAGNOSTIC ULTRASOUND AND TRANSDUCERS
K003121 · IYO
Radiology · 15d
Cleared Aug 01, 2000
SONOACE SA 9900 DIAGNOSTIC ULTRASOUND SYSTEM
K002185 · IYN
Radiology · 13d
Cleared Jan 19, 2000
SONOACE 600 DIAGNOSTIC ULTRASOUND SYSTEM
K000030 · IYO
Radiology · 14d
Cleared Nov 02, 1999
COMBISON 530D/VOLUSON 530D, TISSUE HARMONIC IMAGING (THI) OPTION
K993517 · IYO
Radiology · 15d
Cleared Sep 01, 1999
SONOACE 5500 DIAGNOSTIC ULTRASOUND SYSTEM
K992761 · IYO
Radiology · 15d
Cleared Jul 12, 1999
THE S-VNA 5-8(B) DIAGNOSTIC ULTRASOUND TRANSDUCER
K984639 · ITX
Radiology · 193d
Cleared Jul 08, 1999
VOLUSION SMALL PARTS TRANSDUCER, MODEL S-VNW 5-10, VOLUSION ABDOMINAL...
K992155 · ITX
Radiology · 13d
Cleared Apr 07, 1999
SONOACE 6000C DIAGNOSTIC ULTRASOUND SYSTEM AND TRANSDUCERS, ALSO CALLED...
K990970 · IYN
Radiology · 15d
Cleared Sep 29, 1998
COMBISON 530D WITH POWER DOPPLER MODE
K974813 · IYN
Radiology · 280d
Cleared Aug 21, 1998
SA8800 DIAGNOSTIC ULTRASOUND SYSTEM AND TRANSDUCERS,
K974269 · IYN
Radiology · 281d
Cleared May 08, 1998
SONOACE 6000/ ULTRAMARK 400
K981510 · IYO
Radiology · 10d
Cleared Feb 19, 1997
COMBISON 530 DIAGNOSTIC ULTRASOUND SCANNER
K940942 · IYO
Radiology · 1086d
Cleared Mar 14, 1996
6.5 MHZ ENDORECTAL CONVEX ARRAY (10R) PROBE
K953773 · IYO
Radiology · 213d
Cleared Dec 27, 1994
MEDISON 4800
K925582 · IYO
Radiology · 782d
Cleared Nov 03, 1993
MEDISON 88P DIAGNOSTIC ULTRASOUND IMAGING SYTEM
K930579 · IYO
Radiology · 272d
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