ClearanceBrief
Company ยท US

Aloka Co., Ltd.

FDA 510(k) clearances and medical device recalls filed under this name, 1982 to 2011. Name variants (Inc, Corp, punctuation) are merged.

41510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)

Product codes

CodeDeviceRecords
IYNSystem, Imaging, Pulsed Doppler, Ultrasonic18
IYOSystem, Imaging, Pulsed Echo, Ultrasonic9
ITXTransducer, Ultrasonic, Diagnostic8
KRKManometer, Blood-Pressure, Venous1
LLZSystem, Image Processing, Radiological1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
May 13, 2011K111227ALOKA SSD-3500 DIAGNOSTIC ULTRASOUND SYSTEM
Aloka Co., Ltd.
IYN
Feb 17, 2011K110207ALOKA PROUSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEM
Aloka Co., Ltd.
IYN
Nov 20, 2009K093488ALOKA PROSOUND ALPHA 6 DIAGNOSTIC ULTRASOUND SYSTEM
Aloka Co., Ltd.
IYO
Dec 19, 2008K083254ALOKA PROUSOUND 2 DIAGNOSTIC ULTRASOUND SYSTEM
Aloka Co., Ltd.
IYN
Jul 15, 2008K081843ULTRASOUND DATA ANALYSIS SYSTEM, MODEL DAS-RS1
Aloka Co., Ltd.
LLZ
Feb 29, 2008K080176ALOKA PROSOUND 6 DIAGNOSTIC ULTRASOUND SYSTEM
Aloka Co., Ltd.
IYN
Aug 30, 2007K072285ALOKA SSD-ALPHA 7 ULTRASOUND SYSTEM
Aloka Co., Ltd.
ITX
Jan 13, 2006K060059ALOKA SD-3500 ULTRASOUND SYSTEM
Aloka Co., Ltd.
IYN
Nov 30, 2004K043196ALOKA SSD-ALPHA 10 ULTRASOUND SYSTEM
Aloka Co., Ltd.
IYN
Jul 30, 2004K041916ALOKA SSD-ALPHA 5 ULTRASOUND SYSTEM
Aloka Co. Ltd USA
IYN
Mar 26, 2004K040719ALOKA MODEL SSD-4000 DIAGNOSTIC ULTRASOUND SYSTEM W/OPTIONAL SONOREAL 3D SYSTEM ACCESSORY
Aloka Co., Ltd.
IYO
Oct 29, 2003K033311ALOKA SSD-5000 V5.0 ULTRASOUND SYSTEM
Aloka Co., Ltd.
IYN
Sep 30, 2003K032875ALOKA MODEL SSD-5500 V6.0 ULTRASOUND SYSTEM
Aloka Co. Ltd USA
IYO
Dec 18, 2002K023996ALOKA SSD-3500 ULTRASOUND SYSTEM
Aloka Co., Ltd.
IYN
Jul 10, 2002K020668ALOKA SSD-1000 DIAGNOSTIC ULTRASOUND SYSTEM, MODELS ASU-1003, UST-9121, UST-9124
Aloka Co., Ltd.
IYO
Aug 30, 2001K012253SSD-1000 DIAGNOSTIC ULTRASOUND SYSTEM
Aloka Co., Ltd.
IYO
Aug 29, 2001K012080SSD-5000 DIAGNOSTIC ULTRASOUND SYSTEM
Aloka Co., Ltd.
IYN
May 23, 2001K011457ALOKA SSD-5500 WITH KI AND A-SMA
Aloka Co., Ltd.
IYN
May 15, 2001K011315SSD 5500 WITH OLYMPUS GF TYPE UC140P-AL5
Aloka Co., Ltd.
IYN
May 15, 2001K011314OLYMPUS GF UC140P-AL5 ULTRASONIC ENDOSCOPE WITH ALOKA SSD-5500 ULTRASOUND SYSTEM
Aloka Co., Ltd.
ITX
Dec 27, 2000K003739ALOKA SSD-4000
Aloka Co., Ltd.
IYN
Sep 20, 2000K002784ALOKA UST-5280-5
Aloka Co., Ltd.
ITX
Aug 24, 1999K992663ALOKA SSD-5500 DIAGNOSTIC ULTRASOUND SYSTEM
Aloka Co., Ltd.
IYN
Mar 22, 1999K983879ALOKA SSD-900 DIAGNOSTIC ULTRASOUND SYSTEM
Aloka Co., Ltd.
IYO
Mar 18, 1998K974544ASU-1000 DIAGNOSTIC ULTRASOUND TRANSDUCER
Aloka Co., Ltd.
ITX
Aug 15, 1997K972465ALOKA SSD-1400 DIAGNOSTIC ULTRASOUND SYSTEM
Aloka Co., Ltd.
IYN
Jun 3, 1997K964549ALOKA UST-5258-5 DIAGNOSTIC ULTRASOUND TRANSDUCER
Aloka Co., Ltd.
ITX
Apr 3, 1997K963616ALOKA SSD-1700 DIAGNOSTIC ULTRASOUND SYSTEM
Aloka Co., Ltd.
IYN
Jan 17, 1996K954022ALOKA OMNIVIEW DIAGNOSTIC ULTRASOUND SYSTEM
Aloka Co., Ltd.
IYN
Sep 15, 1995K950607UST-5268P-5 TRANSDUCER
Aloka Co., Ltd.
KRK
Feb 1, 1995K943113SSD-2000 DIAGNOSTIC ULTRASOUND SYSTEM
Aloka Co., Ltd.
IYO
Dec 29, 1994K943637SSD-2000 DIAGNOSTIC ULTRASOUND SYSTEM
Aloka Co., Ltd.
ITX
Oct 21, 1994K941652ALOKA SSD-2000 DIAGNOSTIC ULTRASOUND SYSTEM MODIFICATION
Aloka Co., Ltd.
IYN
Feb 12, 1993K925646SSD-2000 DIAG. ULTRASOUND SYS.&UST-979-3.5 TRANS.
Aloka Co., Ltd.
IYO
Feb 12, 1993K925486UST-5522-7.5 & UST-5522L-7.5 INTRAOPERATIVE TRANS.
Aloka Co., Ltd.
ITX
Dec 3, 1992K923269CONVEX AND LINEAR ARRAY TRANSDUCERS
Aloka Co., Ltd.
IYO
Sep 21, 1992K922549UST-665P-5, UST-664-5/7.5, ASU-35WL-10, SCU-35
Aloka Co., Ltd.
ITX
May 9, 1983K837304MODELS 246 AND 210F LINEAR ARRAY ULTRASOUND SCANNER
Aloka Co., Ltd., JP
Apr 25, 1982K827177LTRASONIC SCANNER U.S. ALOKA SSD-500
Aloka Co., Ltd., JP
Apr 21, 1982K827285MODEL SSD-710
Aloka Co., Ltd., JP
Apr 21, 1982K827284MODEL SSD-119
Aloka Co., Ltd.

Latest recalls

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