Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Shimadzu Medical Systems · Predicate Candidate Screening

90 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

74 daysmedian FDA review time

197 days90th percentile

90clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K082224	DIAGNOSTIC ULTRASOUND SYSTEM SARANO, ECHO VIEW, SHIMASONIC	Shimadzu Medical Systems	2008-12-15	131	0
K071289	ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SD	Shimadzu Medical Systems	2008-01-09	246	0
K071291	ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SD	Shimadzu Medical Systems	2008-01-09	246	0
K071287	ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND DEVICE, MODEL SD	Shimadzu Medical Systems	2008-01-09	246	0
K061643	ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU	Shimadzu Medical Systems	2006-07-27	45	0
K061637	ECHOVIEW/ SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU	Shimadzu Medical Systems	2006-07-25	43	0
K061641	ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SAR	Shimadzu Medical Systems	2006-07-14	32	0
K052500	DAR-8000F	Shimadzu Medical Systems	2005-10-17	34	1
K052076	DAR-8000I	Shimadzu Medical Systems	2005-09-02	32	0
K050510	ECHOVIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-	Shimadzu Medical Systems	2005-04-01	31	0
K003514	ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU	Shimadzu Medical Systems	2001-02-12	90	0
K003515	ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU	Shimadzu Medical Systems	2001-02-12	90	0
K994431	SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-78	Shimadzu Medical Systems	2000-03-23	84	0
K984156	SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-70	Shimadzu Medical Systems	1999-04-21	153	0
K980837	SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-70	Shimadzu Medical Systems	1998-05-20	77	0
K973802	SHIMASONIC LINEAR/CONVEX DIAGNOSTIC ULTRASOUND SYSTEM	Shimadzu Medical Systems	1998-03-04	149	0
K973329	SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-68	Shimadzu Medical Systems	1997-10-08	34	0
K973327	SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-68	Shimadzu Medical Systems	1997-10-08	34	0
K970508	ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM	Shimadzu Medical Systems	1997-08-04	175	0
K963888	C-ARM TABLE IVS-100	Shimadzu Medical Systems	1996-12-18	83	0
K963617	SHIMADZU X-RAY DIAGNOSTIC TABLE YSF-120	Shimadzu Medical Systems	1996-11-08	59	0
K953634	SHIMASONIC SDU-350 ELECTRONIC LINEAR/CONVEX DIAGNOSTIC ULTRA	Shimadzu Medical Systems	1996-02-13	195	0
K955255	SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-7000TX	Shimadzu Medical Systems	1996-02-09	88	0
K955253	SHIMADZU WHOLE BODY X-RAY SCANNER SCT-7000TH	Shimadzu Medical Systems	1996-01-26	74	0
K955254	SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-7000TC	Shimadzu Medical Systems	1996-01-26	74	0
K955395	DAR-2400-15B/30B	Shimadzu Medical Systems	1995-12-11	17	0
K936236	SHIMADZU IMAGE AMPLIFIER IA-12LM SERIES	Shimadzu Medical Systems	1995-05-11	497	0
K951315	CATHETERIZATION TABLE KS-60	Shimadzu Medical Systems	1995-05-11	49	0
K945453	UD 150L-R II	Shimadzu Medical Systems	1995-03-21	134	0
K945452	UD 150L-F	Shimadzu Medical Systems	1995-03-21	134	0
K943545	CEILING SUSPENDED C-ARM SUPPORT MH-100	Shimadzu Medical Systems	1995-02-03	197	0
K942669	SMT-50CX/H	Shimadzu Medical Systems	1995-02-02	241	0
K931021	SHIMASONIC SDU-400 ELECTRONIC LINEAR/CONVEX D.U.S.	Shimadzu Medical Systems	1994-11-14	623	0
K932244	SMT-100X/H AND SMT-100X/X MAGNETIC RESONANCE IMAGING SYSTEM	Shimadzu Medical Systems	1994-02-18	284	0
K923984	SMT-50X/H MAGNETIC RESONANCE IMAGING SYSTEM	Shimadzu Medical Systems	1993-03-16	221	0
K925107	SMT-50XM MAGNETIC RESONANCE IMAGING SYSTEM	Shimadzu Medical Systems	1993-01-15	98	0
K925170	SHIMADZU X-RAY TUBE STAND BH-100 SERIES	Shimadzu Medical Systems	1992-12-07	55	0
K925169	SHIMADZU RADIOGRAPJHIC STAND BR-100	Shimadzu Medical Systems	1992-12-03	51	0
K925175	SHIMADZU X-RAY DIAGNOSTIC TABLE YSF-200 30/90	Shimadzu Medical Systems	1992-11-27	45	0
K925174	SHIMADZU RADIOGRAPHIC TABLE BK-100	Shimadzu Medical Systems	1992-11-27	45	0
K923453	SHIMADZU IMAGE AMPLIFIER IA-9LM SERIES	Shimadzu Medical Systems	1992-10-05	83	0
K923454	SHIMADZU IMAGE AMPLIFIER IA-9LS SERIES	Shimadzu Medical Systems	1992-10-05	83	0
K922012	SHIMADZU IMAGE AMPLIFIER IA-12VSA SERIES	Shimadzu Medical Systems	1992-06-16	48	0
K922013	SHIMADZU IMAGE AMPLIFIER IA-12VMA SERIES	Shimadzu Medical Systems	1992-06-10	42	0
K922011	SHIMADZU IMAGE AMPLIFIER IA-12VDA SERIES	Shimadzu Medical Systems	1992-06-10	42	0
K920726	UROLOGICAL X-RAY TABLE HS-10A	Shimadzu Medical Systems	1992-05-29	101	0
K920731	X-RAY TUBE ASSEMBLY CIRCLEX1.2UG	Shimadzu Medical Systems	1992-05-29	101	0
K921432	SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-4500TF	Shimadzu Medical Systems	1992-05-28	64	0
K920728	X-RAY DIAGNOSTIC TABLE YSF-100	Shimadzu Medical Systems	1992-05-28	100	0
K920724	HIGH SPEED ROTATION STARTER SA-50	Shimadzu Medical Systems	1992-04-27	69	0

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda