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510(k) Data Aggregation
K Number
K110920Device Name
UF-760AG
Manufacturer
Date Cleared
2011-04-08
(7 days)
Regulation Number
892.1570Why did this record match?
Applicant Name (Manufacturer) :
FUKUDA DENSHI CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The system is intended for use by a qualified physician for diagnostic ultrasound imaging or fluid flow analysis of the human body in Fetal/Obstetric, Gynecological, Abdominal (renal, Gyn/Pelvic), Small Organ (thyroid, breast, testes, etc.), Adult Cephalic, Trans-cranial, Musculoskeletal (conventional & superficial), Cardiac-Adult/Pediatric/Fetal. Transesophageal (Cardiac), Peripheral vascular.
The UF-760AG ultrasound instrument is intended to perform the following diagnostic ultrasound investigations: Imaging (B-mode, 3D/4D, harmonic imaging), Time motion (M-mode), Pulsed wave Doppler (PW Doppler), Continuous wave Doppler (CW Doppler), Power Doppler Tissue Imaging, Color Flow Mapping (CFM) and Color Time Motion (CM)
Device Description
The UF-760AG ultrasound instrument is intended to perform the following diagnostic ultrasound investigations: Imaging (B-mode, 3D/4D), Time motion (M-mode), Pulsed wave Doppler (PW Doppler), Continuous wave Doppler (CW Doppler), Color Flow Mapping (CFM) and Color Time Motion (CM).
The submission also includes the transducers necessary for these procedures.
The system is a portable unit approximately 14.5" wide, 14.4" deep and 3.9" high equipped with a keyboard control panel, a 15" TFT screen, assorted transducers and image storage or hard-copy devices.
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K Number
K081919Device Name
UF-870 AG DIAGNOSTIC ULTRASOUND SYSTEM
Manufacturer
Date Cleared
2008-09-09
(64 days)
Regulation Number
892.1570Why did this record match?
Applicant Name (Manufacturer) :
FUKUDA DENSHI CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal, Pediatric, Small organs (Thyroid, Breast, Testicle), Adult Cephalic, Cardiac, Transesophageal, Transvaginal, Peripheral Vascular, Musculo-skeletal Conventional, Musculo-skeletal Superficial.
Mode of Operation: A, B, M, PW D, CW D, Color Doppler, Amplitude Doppler, Combined (B + M, B + PWD, Color Doppler + PWD, Amplitude Doppler + PWD).
Device Description
The UF-870AG is an ultrasound instrument intended to perform the following diagnostic ultrasound investigations: Imaging (B-mode), Time motion (M-mode), Pulsed wave Doppler (PW Doppler), Continuous wave Doppler (CW Doppler), Color Flow Mapping (CFM) and Color Time motion (CM mode). The submission also includes the transducers necessary for these procedures. The system is a mobile console approximately 19" wide, 31" deep and 53-57" high equipped with a keyboard control panal, a large TFT screen, assorted transducers and image storage or hard-copy devices.
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