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510(k) Data Aggregation
K Number
K160559Device Name
NOBLUS Ultrasound Diagnostic System
Manufacturer
HITACHI MEDICAL CORPORATION
Date Cleared
2016-10-18
(232 days)
Product Code
IYN, ITX, IYO
Regulation Number
892.1550Why did this record match?
Applicant Name (Manufacturer) :
HITACHI MEDICAL CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The 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.), Intra-operative (Neuro.), Transesophageal (Cardiac) - Adult/Pediatric, Wound (Cavernous/Non-Cavernous), Fetal, Pediatric, Small Organ, Peripheral vessel, Biopsy, Trans-rectal, Musculoskeletal (Convent. / Superfic.), 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, M mode (Pulse Wave Doppler), CW mode (Continuous Wave Doppler), Color Doppler (Color Flow Angiography), TDI (Tissue Doppler Imaging), 3D Imaging, 4D 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 O
- Ultrasound transducer accessories (standard and optional) to maximize functional usage of transducer(s) O in various modes of operation
- A computer system to control the transducer and analyze the signals resulting from the reflected echoes O
- A video monitor with optional image recorder to display the computed image or derived Doppler data O
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