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

100 results for "Hitachi Medical Systems America, Inc."
1–24 of 100
Search insights Median review: 78d Cleared: 100% Top manufacturer: Hitachi Medical Systems America, Inc. Lead specialty: Radiology
Cleared Mar 03, 2017
HITACHI Supria Whole-body X-ray CT System Phase 3
K163528 · JAK
Hitachi Medical Systems America, Inc.
Radiology · 77d
Cleared Sep 16, 2016
TRILLIUM Oval Head Coil 32
K162079 · MOS
Hitachi Medical Systems America, Inc.
Radiology · 51d
Cleared Aug 17, 2016
SUPRIA w/guideShot Option
K161748 · JAK
Hitachi Medical Systems America, Inc.
Radiology · 54d
Cleared May 20, 2016
Trillium Oval V 5.1 MRI System
K160152 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 119d
Cleared Mar 31, 2016
ECHELON Oval V 5.1 MRI System
K153547 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 111d
Cleared Oct 30, 2015
SCENARIA Phase 3 Whole-body X-ray CT System
K150595 · JAK
Hitachi Medical Systems America, Inc.
Radiology · 235d
Cleared Sep 30, 2015
Supria Whole-body X-ray CT System
K150565 · JAK
Hitachi Medical Systems America, Inc.
Radiology · 208d
Cleared Jul 29, 2015
ECHELON Oval V 5.0 MRI System
K151015 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 104d
Cleared Mar 06, 2015
Sirius Starmobile tiara
K143537 · IZL
Hitachi Medical Systems America, Inc.
Radiology · 81d
Cleared Mar 02, 2015
TRILLIUM Oval MR System
K142734 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 160d
Cleared Mar 29, 2013
SCENARIA PHASE 2 WHOLE-BODY X-RAY CT SYSTEM
K123509 · JAK
Hitachi Medical Systems America, Inc.
Radiology · 136d
Cleared May 03, 2012
GUIDESHOT OPTION, SCENARIA WHOLE-BODY X-RAY CT SYSTEM
K113341 · JAK
Hitachi Medical Systems America, Inc.
Radiology · 171d
Cleared May 01, 2012
ECHELON OVAL MRI SYSTEM
K113145 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 189d
Cleared Sep 27, 2011
HI VISION ASCENDUS DIAGNOSTIC ULTRASOUND SCANNER
K110673 · IYN
Hitachi Medical Systems America, Inc.
Radiology · 202d
Cleared Apr 08, 2011
SCENARIA WHOLE-BODY X-RAY CT SYSTEM
K101888 · JAK
Hitachi Medical Systems America, Inc.
Radiology · 275d
Cleared Feb 25, 2011
ECHELON RAPID CARDIAC COIL
K110120 · MOS
Hitachi Medical Systems America, Inc.
Radiology · 38d
Cleared Dec 20, 2010
HITACHI ECHELON NV ATTACHMENT AND SMALL EXTREMITY COILS MODEL ECHELON
K102889 · MOS
Hitachi Medical Systems America, Inc.
Radiology · 81d
Cleared Oct 27, 2010
HI VISION AVIUS DIAGNOSTIC ULTRASOUND SCANNER
K102901 · IYN
Hitachi Medical Systems America, Inc.
Radiology · 27d
Cleared Jun 17, 2010
HI VISION PREIRUS DOAGNOSTIC ULTRASOUND SCANNER MODEL HI VISION PREIRUS
K093466 · IYO
Hitachi Medical Systems America, Inc.
Radiology · 223d
Cleared Mar 16, 2010
OASIS MRI SYSTEM
K093044 · LNI
Hitachi Medical Systems America, Inc.
Radiology · 167d
Cleared Jun 15, 2009
GUIDESHOT OPTION FOR CXR4 AND ECLOS CT SYSTEMS
K091103 · JAK
Hitachi Medical Systems America, Inc.
Radiology · 60d
Cleared Feb 17, 2009
ECHELON C MRI SYSTEM
K083533 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 81d
Cleared Dec 05, 2008
ECHELON HIGH RESOLUTION FOOT COIL (MR-HRF-150), ECHELON LONG BONE COIL...
K083086 · MOS
Hitachi Medical Systems America, Inc.
Radiology · 50d
Cleared Aug 12, 2008
ECHELON RAPID PV COIL, MODEL MR-PVC-150, ECHELON RAPID FOOT COIL, MODEL...
K081745 · MOS
Hitachi Medical Systems America, Inc.
Radiology · 54d