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."
25–48 of 100
Search insights Median review: 78d Cleared: 100% Top manufacturer: Hitachi Medical Systems America, Inc. Lead specialty: Radiology
Cleared Jun 18, 2008
ECHELON RAPID HEAD COIL, MODEL MR-RHC-150N, ECHELON RAPID TORSO COIL, MODEL...
K081198 · MOS
Hitachi Medical Systems America, Inc.
Radiology · 51d
Cleared Feb 11, 2008
OASIS RAPID BREAST COIL, MODEL MR-IBC-120 AND OASIS RAPID NV COIL, MODEL...
K080062 · MOS
Hitachi Medical Systems America, Inc.
Radiology · 33d
Cleared Sep 21, 2007
MAGNETIC RESONANCE DIAGNOSTIC DEVICE
K072279 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 36d
Cleared Aug 28, 2007
ECLOS COMPUTED TOMOGRAPHY X-RAY SYSTEM
K071806 · JAK
Hitachi Medical Systems America, Inc.
Radiology · 57d
Cleared Jun 28, 2007
ECHELON SPECTROSCOPY PACKAGE
K071506 · LNI
Hitachi Medical Systems America, Inc.
Radiology · 27d
Cleared Dec 21, 2006
HI VISION 900 DIAGNOSTIC ULTRASOUND SCANNER
K063518 · IYN
Hitachi Medical Systems America, Inc.
Radiology · 30d
Cleared Dec 12, 2006
ECHELON MR-RCC-150 CARDIAC COIL
K063513 · MOS
Hitachi Medical Systems America, Inc.
Radiology · 21d
Cleared Oct 05, 2006
ECHELON SHOULDER COIL
K062556 · MOS
Hitachi Medical Systems America, Inc.
Radiology · 36d
Cleared Aug 18, 2006
HHF1 ECHELON MULTI-PURPOSE COIL
K061950 · MOS
Hitachi Medical Systems America, Inc.
Radiology · 39d
Cleared Feb 17, 2006
CXR16
K053148 · JAK
Hitachi Medical Systems America, Inc.
Radiology · 99d
Cleared Jan 24, 2006
ALTAIRE INTERVENTIONAL MR PACKAGE
K053309 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 57d
Cleared Sep 27, 2005
HHF1 MAGNETIC RESONANCE IMAGING SYSTEM
K052172 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 49d
Cleared Apr 07, 2005
ALTAIRE
K050602 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 29d
Cleared Feb 28, 2005
AIRIS ELITE RAPID BODY COIL
K050307 · MOS
Hitachi Medical Systems America, Inc.
Radiology · 20d
Cleared Sep 17, 2004
SCEPTREP3 PET/CT
K042428 · KPS
Hitachi Medical Systems America, Inc.
Radiology · 9d
Cleared Apr 21, 2004
HITACHI PRESTO
K040902 · JAK
Hitachi Medical Systems America, Inc.
Radiology · 14d
Cleared Oct 20, 2003
HITACHI CB MERCURAY DENTAL CONE-BEAM X-RAY SYSTEM
K033248 · MUH
Hitachi Medical Systems America, Inc.
Radiology · 13d
Cleared Sep 29, 2003
AIRIS ELITE MAGNETIC RESONANCE IMAGING DEVICE
K032232 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 70d
Cleared Aug 22, 2003
EUB-5500 DIAGNOSTIC ULTRASOUND SCANNER
K032503 · IYN
Hitachi Medical Systems America, Inc.
Radiology · 9d
Cleared Oct 11, 2002
HITACHI ALTAIRE
K022390 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 80d
Cleared Aug 15, 2002
ALTAIRE MAGNETIC RESONANCE IMAGING SYSTEM
K021751 · MOS
Hitachi Medical Systems America, Inc.
Radiology · 79d
Cleared Jul 02, 2002
SCEPTRE-VS
K021314 · LLZ
Hitachi Medical Systems America, Inc.
Radiology · 68d
Cleared Mar 22, 2002
PRONTO
K014240 · JAK
Hitachi Medical Systems America, Inc.
Radiology · 86d
Cleared Aug 09, 2001
ETG-100 OPTICAL ENCEPHALOGRAPHY SYSTEM
K011320 · DQA
Hitachi Medical Systems America, Inc.
Anesthesiology · 100d