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510(k) Data Aggregation
K Number
K142368Device Name
NOBLUS DIAGNOSTIC ULTRASOUND SCANNER
Manufacturer
HITACHI ALOKA MEDICAL, LTD.
Date Cleared
2015-01-14
(142 days)
Product Code
IYN, ITX, IYO
Regulation Number
892.1550Why did this record match?
Applicant Name (Manufacturer) :
HITACHI ALOKA MEDICAL, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Hitachi Noblus™ Ultrasound Diagnostic System is intended for use by trained personnel (doctor, sonographer, etc.) for the diagnostic ultrasound evaluation of Abdominal, Cardiac, Intra-operative (Spec.), Trans-esophageal (Cardiac, Non-Cardiac) - Adult/Pediatric, Wound (Cavernous), Fetal, Pediatric, Small Organ, Peripheral vessel, Biospy, Trans-rectal, Trans-vaginal, Musculoskeletal (Convent. / Superfic.), Neonatal Cephalic, Adult Cephalic, Endoscopy, Intraluminal, Gynecology, Urology, and Laparoscopic clinical applications.
The modes of operation of the Hitachi Noblus™ Ultrasound Diagnostic System are B mode, M mode, PW mode (Pulse Wave Doppler), CW mode (Continuous Wave Doppler, Amplitude Doppler (Color Flow Angiography), TDI (Tissue Doppler Imaging), 3D Imaging and Real Time Tissue Elastography.
Device Description
An ultrasound diagnostic system with the following features:
- Ultrasound transducer(s) to generate the transmitted ultrasound energy and detect the reflected echoes
- Ultrasound transducer accessories (standard and optional) to maximize functional usage of transducer(s) in various modes of operation
- A computer system to control the transducer and analyze the signals resulting from the reflected echoes
- A standard Lithium ion computer battery to allow for system portability
- A video monitor with optional image recorder to display the computed image or derived Doppler data
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K Number
K140854Device Name
INTRA-OPERATIVE ULTRASOUND TRANSDUCER
Manufacturer
HITACHI ALOKA MEDICAL, LTD.
Date Cleared
2014-06-11
(69 days)
Product Code
ITX, DEV
Regulation Number
892.1570Why did this record match?
Applicant Name (Manufacturer) :
HITACHI ALOKA MEDICAL, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Hitachi Aloka Medical. Ltd. UST-5310 / UST-5311 transducers for use with the PROSOUND ALPHA6 Diagnostic Citrasound scanner are intended for use by trained personnel (doctor, sonographer, etc.) for the diagnostic ultrassund evaluation during Intra-operative and Intra-operative (neurosurgery) procedures.
The device is not indicated for Ophthalmic applications.
Device Description
Linear Array transducer
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K Number
K140639Device Name
PROSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEM
Manufacturer
HITACHI ALOKA MEDICAL, LTD.
Date Cleared
2014-04-16
(35 days)
Product Code
IYN, ITX, IYO
Regulation Number
892.1550Why did this record match?
Applicant Name (Manufacturer) :
HITACHI ALOKA MEDICAL, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Hitachi Aloka Medical, Ltd. Prosound F75 is intended for use by trained personnel (doctor, sonographer, etc.) for the diagnostic ultrasound evaluation of Fetal; Abdominal; Intra-operative (neurosurgery); Laparoscopic; Pediatric; Small Organ; Neonatal Cephalic; Trans-rectal; Trans-vaginal; TEE (non-cardiac); Musculo-skeletal; Cardiac Adult; Cardiac Adult - TEE; Cardiac Neonatal; Cardiac Pediatric - TEE; Peripheral Vascular; and Gynecological applications. The device is not indicated for Ophthalmic applications.
Device Description
An ultrasound diagnostic system with the following features:
- Ultrasound transducer(s) = to generate the transmitted ultrasound energy and detect the reflected echoes
- Ultrasound transducer accessories (standard and optional) to maximize functional usage of transducer(s) in various modes of operation
- A computer system to control the transducer and analyze the signals resulting from the reflected echoes
- A video monitor with optional image recorder to display the computed image or derived Doppler data
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K Number
K130308Device Name
NOBLUS ULTRASOUND DIAGNOSTIC SYSTEM
Manufacturer
HITACHI ALOKA MEDICAL, LTD.
Date Cleared
2013-04-05
(57 days)
Product Code
IYN, ITX, IYO
Regulation Number
892.1550Why did this record match?
Applicant Name (Manufacturer) :
HITACHI ALOKA MEDICAL, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Hitachi Noblus™ Ultrasound Diagnostic System is intended for use by trained personnel (doctor, sonographer, etc.) for the diagnostic ultrasound evaluation of Abdominal, Cardiac, Intra-operative, Fetal, Pediatric, Small Organ, Peripheral vessel, Biopsy, Trans-rectal, Trans-vaginal, Musculoskeletal, Neonatal, Cephalic, Adult Cephalic, Endoscopy, Intra-luminal, Gynecology, Urology, and Laparoscopic clinical applications.
The modes of Operation of the Hitachi Noblus™ Ultrasound Diagnostic System are B mode, PW mode (Pulse Wave Doppler), CW mode (Continuous Wave Doppler), Color Doppler, Amplitude Doppler (Color Flow Angiography), TDI (Tissue Doppler Imaging), 3D Imaging, and Real Time Tissue Elastography.
Device Description
An ultrasound diagnostic system with the following features:
- Ultrasound transducer(s) to generate the transmitted ultrasound energy and detect the reflected echoes
- Ultrasound transducer accessories (standard and optional) to maximize functional usage of transducer(s) in various modes of operation
- A computer system to control the transducer and analyze the signals resulting from the reflected echoes
- A standard Lithium ion computer battery to allow for system portability
- A video monitor with optional image recorder to display the computed image or derived Doppler data
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K Number
K123828Device Name
PROSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEM
Manufacturer
HITACHI ALOKA MEDICAL, LTD.
Date Cleared
2013-01-18
(37 days)
Product Code
IYN, ITX, IYO
Regulation Number
892.1550Why did this record match?
Applicant Name (Manufacturer) :
HITACHI ALOKA MEDICAL, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Intra-operative; Intra-operative (Neurosurgery); Pediatric; Small Organ; Neonatal Cephalic; Trans-rectal; Trans-vaginal; TEE (non-cardiac); Musculo-skeletal; Cardiac Adult; Cardiac, Adult -TEE; Cardiac - Neonatal; Cardiac - Pediatric; Cardiac Pediatric, TEE; Peripheral Vascular; and Gynecological applications. The device is not indicated for Ophthalmic applications.
Device Description
The Prosound F75, formerly named Aloka Prosound F75, Diagnostic Ultrasound System is a full feature imaging and analysis system. It consist of a mobile console that provides acquisition, processing and display capability. The user interface includes a computer type keyboard, specialized controls and a display. The changes made to the Prosound F75 are the expanded indications: Adult/ Pediatric Cardiac- TEE, Neonatal/Pediatric, Cardiac, Intraoperative Neurosurgery, and Trans-esoph (non-cardiac).
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K Number
K122341Device Name
PROSOUND F37 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL: PROSOUND F37
Manufacturer
HITACHI ALOKA MEDICAL, LTD.
Date Cleared
2012-09-26
(55 days)
Product Code
IYN, ITX, IYO
Regulation Number
892.1550Why did this record match?
Applicant Name (Manufacturer) :
HITACHI ALOKA MEDICAL, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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