Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

95 results for "Shimadzu Medical Systems"
1–24 of 95
Search insights Median review: 77d Cleared: 100% Top manufacturer: Shimadzu Medical Systems Lead specialty: Radiology
Cleared Mar 30, 2018
RADspeed fit
K173517 · KPR
Shimadzu Corporation
Radiology · 136d
Cleared Jul 15, 2016
FDR Visionary Suite
K152294 · KPR
Shimadzu Corporation
Radiology · 337d
Cleared Jun 20, 2016
RADspeed Pro
K152244 · KPR
Shimadzu Corporation
Radiology · 315d
Cleared Mar 06, 2015
X-RAY TV SYSTEM SONIALVISION G4
K142341 · JAA
Shimadzu Corp.
Radiology · 197d
Cleared Feb 26, 2014
TRINIAS
K123508 · OWB
Shimadzu Corporation
Radiology · 470d
Cleared Dec 15, 2008
DIAGNOSTIC ULTRASOUND SYSTEM SARANO, ECHO VIEW, SHIMASONIC
K082224 · ITX
Shimadzu Medical Systems
Radiology · 131d
Cleared Jan 09, 2008
ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1100
K071291 · ITX
Shimadzu Medical Systems
Radiology · 246d
Cleared Jan 09, 2008
ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200PRO
K071289 · ITX
Shimadzu Medical Systems
Radiology · 246d
Cleared Jan 09, 2008
ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND DEVICE, MODEL SDU-2200PRO
K071287 · ITX
Shimadzu Medical Systems
Radiology · 246d
Cleared Jul 27, 2006
ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200PRO
K061643 · IYN
Shimadzu Medical Systems
Radiology · 45d
Cleared Jul 25, 2006
ECHOVIEW/ SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-2200PRO
K061637 · IYN
Shimadzu Medical Systems
Radiology · 43d
Cleared Jul 14, 2006
ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SARANO
K061641 · IYO
Shimadzu Medical Systems
Radiology · 32d
Cleared Oct 17, 2005
DAR-8000F
K052500 · IZI
Shimadzu Medical Systems
Radiology · 34d
Cleared Sep 02, 2005
DAR-8000I
K052076 · IZI
Shimadzu Medical Systems
Radiology · 32d
Cleared Apr 01, 2005
ECHOVIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1100
K050510 · IYN
Shimadzu Medical Systems
Radiology · 31d
Cleared Feb 12, 2001
ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200
K003515 · IYN
Shimadzu Medical Systems
Radiology · 90d
Cleared Feb 12, 2001
ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-2200
K003514 · IYN
Shimadzu Medical Systems
Radiology · 90d
Cleared Mar 23, 2000
SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7800 SERIES
K994431 · JAK
Shimadzu Medical Systems
Radiology · 84d
Cleared Apr 21, 1999
SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7000TX W/FLURO OPTION
K984156 · JAK
Shimadzu Medical Systems
Radiology · 153d
Cleared May 20, 1998
SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7000TS
K980837 · JAK
Shimadzu Medical Systems
Radiology · 77d
Cleared Mar 04, 1998
SHIMASONIC LINEAR/CONVEX DIAGNOSTIC ULTRASOUND SYSTEM
K973802 · IYO
Shimadzu Medical Systems
Radiology · 149d
Cleared Oct 08, 1997
SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-6800TX
K973329 · JAK
Shimadzu Medical Systems
Radiology · 34d
Cleared Oct 08, 1997
SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-6800TH
K973327 · JAK
Shimadzu Medical Systems
Radiology · 34d
Cleared Aug 04, 1997
ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM
K970508 · IYO
Shimadzu Medical Systems
Radiology · 175d