Shimadzu Medical Systems

FDA Filings

This page includes the latest FDA filings for Shimadzu Medical Systems. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Shimadzu Medical Systems holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

FDA Registration(s)

Registration Number	1000125362
FEI Number	1000125362
Name	SHIMADZU MEDICAL SYSTEMS
Owner & Operator	SHIMADZU MEDICAL SYSTEMS
Contact Address	20101 SOUTH VERMONT AVE. -- Torrance CA 90502 US
Official Correspondent	Akinori - Yamaguchi x-310-2178855-117
Registration Status	1
Initial Importer	Y
Registration Expiration	2020-04-25
Registration Address	20101 S Vermont Ave TORRANCE, CA 90502 US

FDA Filings

Device Company	Device	Date
PMN K082224 SHIMADZU MEDICAL SYSTEMS	DIAGNOSTIC ULTRASOUND SYSTEM SARANO, ECHO VIEW, SHIMASONIC	2008-12-15
PMN K071291 SHIMADZU MEDICAL SYSTEMS	ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1100	2008-01-09
PMN K071289 SHIMADZU MEDICAL SYSTEMS	ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200PRO	2008-01-09
PMN K071287 SHIMADZU MEDICAL SYSTEMS	ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND DEVICE, MODEL SDU-2200PRO	2008-01-09
PMN K061643 SHIMADZU MEDICAL SYSTEMS	ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200PRO	2006-07-27
PMN K061637 SHIMADZU MEDICAL SYSTEMS	ECHOVIEW/ SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-2200PRO	2006-07-25
PMN K052500 SHIMADZU MEDICAL SYSTEMS	DAR-8000F	2005-10-17
PMN K052076 SHIMADZU MEDICAL SYSTEMS	DAR-8000I	2005-09-02
PMN K050510 SHIMADZU MEDICAL SYSTEMS	ECHOVIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1100	2005-04-01
PMN K003514 SHIMADZU MEDICAL SYSTEMS	ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-2200	2001-02-12
PMN K994431 SHIMADZU MEDICAL SYSTEMS	SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7800 SERIES	2000-03-23
PMN K984156 SHIMADZU MEDICAL SYSTEMS	SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7000TX W/FLURO OPTION	1999-04-21
PMN K980837 SHIMADZU MEDICAL SYSTEMS	SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7000TS	1998-05-20
PMN K973802 SHIMADZU MEDICAL SYSTEMS	SHIMASONIC LINEAR/CONVEX DIAGNOSTIC ULTRASOUND SYSTEM	1998-03-04
PMN K973329 SHIMADZU MEDICAL SYSTEMS	SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-6800TX	1997-10-08
PMN K973327 SHIMADZU MEDICAL SYSTEMS	SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-6800TH	1997-10-08
PMN K970508 SHIMADZU MEDICAL SYSTEMS	ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM	1997-08-04
PMN K963888 SHIMADZU MEDICAL SYSTEMS	C-ARM TABLE IVS-100	1996-12-18
PMN K963617 SHIMADZU MEDICAL SYSTEMS	SHIMADZU X-RAY DIAGNOSTIC TABLE YSF-120	1996-11-08
PMN K953634 SHIMADZU MEDICAL SYSTEMS	SHIMASONIC SDU-350 ELECTRONIC LINEAR/CONVEX DIAGNOSTIC ULTRASOUND SYSTEM	1996-02-13
PMN K955255 SHIMADZU MEDICAL SYSTEMS	SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-7000TX	1996-02-09
PMN K955254 SHIMADZU MEDICAL SYSTEMS	SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-7000TC	1996-01-26
PMN K955253 SHIMADZU MEDICAL SYSTEMS	SHIMADZU WHOLE BODY X-RAY SCANNER SCT-7000TH	1996-01-26
PMN K955395 SHIMADZU MEDICAL SYSTEMS	DAR-2400-15B/30B	1995-12-11
PMN K951315 SHIMADZU MEDICAL SYSTEMS	CATHETERIZATION TABLE KS-60	1995-05-11
PMN K936236 SHIMADZU MEDICAL SYSTEMS	SHIMADZU IMAGE AMPLIFIER IA-12LM SERIES	1995-05-11
PMN K945453 SHIMADZU MEDICAL SYSTEMS	UD 150L-R II	1995-03-21
PMN K945452 SHIMADZU MEDICAL SYSTEMS	UD 150L-F	1995-03-21
PMN K943545 SHIMADZU MEDICAL SYSTEMS	CEILING SUSPENDED C-ARM SUPPORT MH-100	1995-02-03
PMN K942669 SHIMADZU MEDICAL SYSTEMS	SMT-50CX/H	1995-02-02
PMN K931021 SHIMADZU MEDICAL SYSTEMS	SHIMASONIC SDU-400 ELECTRONIC LINEAR/CONVEX D.U.S.	1994-11-14
PMN K932244 SHIMADZU MEDICAL SYSTEMS	SMT-100X/H AND SMT-100X/X MAGNETIC RESONANCE IMAGING SYSTEM	1994-02-18
PMN K923984 SHIMADZU MEDICAL SYSTEMS	SMT-50X/H MAGNETIC RESONANCE IMAGING SYSTEM	1993-03-16
PMN K925107 SHIMADZU MEDICAL SYSTEMS	SMT-50XM MAGNETIC RESONANCE IMAGING SYSTEM	1993-01-15
PMN K925170 SHIMADZU MEDICAL SYSTEMS	SHIMADZU X-RAY TUBE STAND BH-100 SERIES	1992-12-07
PMN K925169 SHIMADZU MEDICAL SYSTEMS	SHIMADZU RADIOGRAPJHIC STAND BR-100	1992-12-03
PMN K925175 SHIMADZU MEDICAL SYSTEMS	SHIMADZU X-RAY DIAGNOSTIC TABLE YSF-200 30/90	1992-11-27
PMN K925174 SHIMADZU MEDICAL SYSTEMS	SHIMADZU RADIOGRAPHIC TABLE BK-100	1992-11-27
PMN K923454 SHIMADZU MEDICAL SYSTEMS	SHIMADZU IMAGE AMPLIFIER IA-9LS SERIES	1992-10-05
PMN K923453 SHIMADZU MEDICAL SYSTEMS	SHIMADZU IMAGE AMPLIFIER IA-9LM SERIES	1992-10-05
PMN K922012 SHIMADZU MEDICAL SYSTEMS	SHIMADZU IMAGE AMPLIFIER IA-12VSA SERIES	1992-06-16
PMN K922013 SHIMADZU MEDICAL SYSTEMS	SHIMADZU IMAGE AMPLIFIER IA-12VMA SERIES	1992-06-10
PMN K922011 SHIMADZU MEDICAL SYSTEMS	SHIMADZU IMAGE AMPLIFIER IA-12VDA SERIES	1992-06-10
PMN K920731 SHIMADZU MEDICAL SYSTEMS	X-RAY TUBE ASSEMBLY CIRCLEX1.2UG	1992-05-29
PMN K920726 SHIMADZU MEDICAL SYSTEMS	UROLOGICAL X-RAY TABLE HS-10A	1992-05-29
PMN K921432 SHIMADZU MEDICAL SYSTEMS	SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-4500TF	1992-05-28
PMN K920728 SHIMADZU MEDICAL SYSTEMS	X-RAY DIAGNOSTIC TABLE YSF-100	1992-05-28
PMN K920730 SHIMADZU MEDICAL SYSTEMS	X-RAY HIGH VOLTAGE GENERATOR ED 125L	1992-04-27
PMN K920729 SHIMADZU MEDICAL SYSTEMS	BUCKY TABLE BK-12	1992-04-27
PMN K920724 SHIMADZU MEDICAL SYSTEMS	HIGH SPEED ROTATION STARTER SA-50	1992-04-27
PMN K920723 SHIMADZU MEDICAL SYSTEMS	HIGH SPEED ROTATION STARTER SA-40	1992-04-27
PMN K920720 SHIMADZU MEDICAL SYSTEMS	DIGITAL RADIOGRAPHY SYSTEM IDR-1000	1992-04-20
PMN K920733 SHIMADZU MEDICAL SYSTEMS	STEREO COLLIMATOR RF-T SERIES	1992-04-16
PMN K920732 SHIMADZU MEDICAL SYSTEMS	CATHERIZATION KS-50	1992-04-16
PMN K920727 SHIMADZU MEDICAL SYSTEMS	CEILING TUBE SUPPORT CH-30X	1992-04-16
PMN K920725 SHIMADZU MEDICAL SYSTEMS	COLLIMATOR F-20	1992-04-16
PMN K920721 SHIMADZU MEDICAL SYSTEMS	DIGITAL RADIOGRAPHY SYSTEM IDR-2000	1992-04-15
PMN K920387 SHIMADZU MEDICAL SYSTEMS	CIRCLEXO.3T X-RAY TUBE ASSEMBLY	1992-04-14
PMN K920722 SHIMADZU MEDICAL SYSTEMS	X-RAY DIAGNOSTIC TABLE YSF-200-30-90	1992-04-13
PMN K920393 SHIMADZU MEDICAL SYSTEMS	MU125M MOBILE X-RAY SYSTEM	1992-04-06
PMN K915623 SHIMADZU MEDICAL SYSTEMS	SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-4500TE	1992-02-14
PMN K914348 SHIMADZU MEDICAL SYSTEMS	ER-1000 CATHERIZATION C-ARM SYSTEMS	1991-11-01
PMN K911975 SHIMADZU MEDICAL SYSTEMS	SMT-100X	1991-10-30
PMN K913147 SHIMADZU MEDICAL SYSTEMS	SHIMADZU MULTI-DIRECTIONAL DIAGNOSTIC TABLE VS-100	1991-09-19
PMN K913065 SHIMADZU MEDICAL SYSTEMS	SHIMADZU X-RAY HIGH VOLTAGE GENERATOR UD150L	1991-09-16
PMN K913064 SHIMADZU MEDICAL SYSTEMS	SHIMADZU X-RAY HIGH VOLTAGE GENERATOR XUD 150L	1991-09-16
PMN K913063 SHIMADZU MEDICAL SYSTEMS	SHIMADZU X-RAY HIGH VOLTAGE GENERATOR XUD150B-10	1991-09-16
PMN K913062 SHIMADZU MEDICAL SYSTEMS	SHIMADZU X-RAY HIGH VOLTAGE GENERATOR UD150B-10	1991-09-16
PMN K911501 SHIMADZU MEDICAL SYSTEMS	SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-5000TX	1991-07-17
PMN K911500 SHIMADZU MEDICAL SYSTEMS	SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-5000TH	1991-07-17
PMN K911280 SHIMADZU MEDICAL SYSTEMS	SHIMADZU X-RAY HIGH-VOLTAGE GENERATOR XUD150B	1991-06-17
PMN K910426 SHIMADZU MEDICAL SYSTEMS	SDU 500 DIAGNOSTIC ULTRASOUND INSTRUMENT	1991-06-06
PMN K911339 SHIMADZU MEDICAL SYSTEMS	SHIMADZU X-RAY HIGH-VOLTAGE GENERATOR XUD150K	1991-04-16
PMN K905132 SHIMADZU MEDICAL SYSTEMS	SHIMADZU IMAGE PROCESSOR DFS-500	1991-04-16
PMN K905634 SHIMADZU MEDICAL SYSTEMS	SMT-50X	1991-04-10
PMN K903941 SHIMADZU MEDICAL SYSTEMS	SHIMADZU DIGITAL SUBTRACTION SYSTEM DAR-2400	1991-02-04
PMN K905153 SHIMADZU MEDICAL SYSTEMS	REMOTE CONTROLLED X-RAY DIAGNOSTIC RS-110	1990-12-11
PMN K905152 SHIMADZU MEDICAL SYSTEMS	REMOTE CONTROLLED X-RAY DIAG. RSZ-200	1990-12-11
PMN K903373 SHIMADZU MEDICAL SYSTEMS	CATHETERIZATION C-ARM SUPPORT MH-51C(F)	1990-11-29
PMN K903372 SHIMADZU MEDICAL SYSTEMS	CATH MULTIDIRECT BI-PLANE RADIO SYST MH-51A/MH-31A	1990-11-29
PMN K903371 SHIMADZU MEDICAL SYSTEMS	CATHETERIZATION C-ARM SUPPORT MH-51B(F)	1990-11-29
PMN K903942 SHIMADZU MEDICAL SYSTEMS	SHIMADZU X-RAY HIGH VOLTAGE GENERATPR AHD150G	1990-10-03
PMN K894888 SHIMADZU MEDICAL SYSTEMS	SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-3000TE	1990-01-23
PMN K894887 SHIMADZU MEDICAL SYSTEMS	SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-3000TF	1989-12-14
PMN K894056 SHIMADZU MEDICAL SYSTEMS	POSITRON EMISSION COMPUTED TOMOGRAPH SET-1400W	1989-11-15
PMN K893744 SHIMADZU MEDICAL SYSTEMS	SMT-50A MAGNETIC RESONANCE IMAGING SYSTEM	1989-11-06
PMN K895188 SHIMADZU MEDICAL SYSTEMS	SHIMADZU X-RAY TUBE STAND FH-31	1989-09-22
PMN K893637 SHIMADZU MEDICAL SYSTEMS	MC125L-50 SHIMADZU MOBILE X-RAY SYSTEM	1989-07-20

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Related Finance Registrations

NCAGE Code	045Y7	SHIMADZU MEDICAL SYSTEMS
CAGE Code	045Y7	SHIMADZU MEDICAL SYSTEMS

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020081349545	Kobe,Japan -> Los Angeles, California	MEDICAL X-RAY EQUIPMENT & PARTS FOR MEDICAL X-RAY EQUIPMENT	28 CTN
2020081349545	Kobe,Japan -> Los Angeles, California	MEDICAL X-RAY EQUIPMENT & PARTS FOR MEDICAL X-RAY EQUIPMENT	28 CTN
2020072442249	Kobe,Japan -> Los Angeles, California	MEDICAL X-RAY EQUIPMENT & PARTS FOR MEDICAL X-RAY EQUIPMENT	36 PKG
2020072442249	Kobe,Japan -> Los Angeles, California	MEDICAL X-RAY EQUIPMENT & PARTS FOR MEDICAL X-RAY EQUIPMENT	36 PKG
2020072442249	Kobe,Japan -> Los Angeles, California	MEDICAL X-RAY EQUIPMENT & PARTS FOR MEDICAL X-RAY EQUIPMENT	36 PKG
2020071741852	Kobe,Japan -> Los Angeles, California	MEDICAL X-RAY EQUIPMENT & PARTS FOR MEDICAL X-RAY EQUIPMENT	26 PKG
2020071741852	Kobe,Japan -> Los Angeles, California	MEDICAL X-RAY EQUIPMENT & PARTS FOR MEDICAL X-RAY EQUIPMENT	26 PKG
2020062639451	Kobe,Japan -> Los Angeles, California	MEDICAL X-RAY EQUIPMENT & PARTS FOR MEDICAL X-RAY EQUIPMENT	34 PKG
2020062639451	Kobe,Japan -> Los Angeles, California	MEDICAL X-RAY EQUIPMENT & PARTS FOR MEDICAL X-RAY EQUIPMENT	34 PKG
2020062639451	Kobe,Japan -> Los Angeles, California	MEDICAL X-RAY EQUIPMENT & PARTS FOR MEDICAL X-RAY EQUIPMENT	34 PKG
2020062639451	Kobe,Japan -> Los Angeles, California	MEDICAL X-RAY EQUIPMENT & PARTS FOR MEDICAL X-RAY EQUIPMENT	34 PKG
2020061847282	Kobe,Japan -> Los Angeles, California	PARTS FOR MEDICAL X-RAY EQUIPMENT	8 PKG
2020050132186	Kobe,Japan -> Los Angeles, California	PARTS FOR MEDICAL X-RAY EQUIPMENT	24 CTN
202004245043	Kobe,Japan -> Los Angeles, California	PARTS FOR MEDICAL X-RAY EQUIPMENT	5 CTN
2020040634084	Kobe,Japan -> Los Angeles, California	PARTS FOR MEDICAL X-RAY EQUIPMENT	5 CTN