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Aloka Co., Ltd.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
39
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K111227ALOKA SSD-3500 DIAGNOSTIC ULTRASOUND SYSTEMMay 13, 2011
K110207ALOKA PROUSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEMFebruary 17, 2011
K093488ALOKA PROSOUND ALPHA 6 DIAGNOSTIC ULTRASOUND SYSTEMNovember 20, 2009
K083254ALOKA PROUSOUND 2 DIAGNOSTIC ULTRASOUND SYSTEMDecember 19, 2008
K081843ULTRASOUND DATA ANALYSIS SYSTEM, MODEL DAS-RS1July 15, 2008
K080176ALOKA PROSOUND 6 DIAGNOSTIC ULTRASOUND SYSTEMFebruary 29, 2008
K072285ALOKA SSD-ALPHA 7 ULTRASOUND SYSTEMAugust 30, 2007
K060059ALOKA SD-3500 ULTRASOUND SYSTEMJanuary 13, 2006
K043196ALOKA SSD-ALPHA 10 ULTRASOUND SYSTEMNovember 30, 2004
K040719ALOKA MODEL SSD-4000 DIAGNOSTIC ULTRASOUND SYSTEM W/OPTIONAL SONOREAL 3D SYSTEM ACCESSORYMarch 26, 2004
K033311ALOKA SSD-5000 V5.0 ULTRASOUND SYSTEMOctober 29, 2003
K023996ALOKA SSD-3500 ULTRASOUND SYSTEMDecember 18, 2002
K020668ALOKA SSD-1000 DIAGNOSTIC ULTRASOUND SYSTEM, MODELS ASU-1003, UST-9121, UST-9124July 10, 2002
K012253SSD-1000 DIAGNOSTIC ULTRASOUND SYSTEMAugust 30, 2001
K012080SSD-5000 DIAGNOSTIC ULTRASOUND SYSTEMAugust 29, 2001
K011457ALOKA SSD-5500 WITH KI AND A-SMAMay 23, 2001
K011314OLYMPUS GF UC140P-AL5 ULTRASONIC ENDOSCOPE WITH ALOKA SSD-5500 ULTRASOUND SYSTEMMay 15, 2001
K011315SSD 5500 WITH OLYMPUS GF TYPE UC140P-AL5May 15, 2001
K003739ALOKA SSD-4000December 27, 2000
K002784ALOKA UST-5280-5September 20, 2000