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Found 20 results
510(k) Data Aggregation
K Number
K023255Device Name
TECHNOS MP, MODEL AU6
Manufacturer
BIOSOUND ESAOTE, INC.
Date Cleared
2003-02-11
(134 days)
Product Code
IYN
Regulation Number
892.1550Why did this record match?
Applicant Name (Manufacturer) :
BIOSOUND ESAOTE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VPan (View Panoramic) Module is being added to the Technos™ ultrasound imaging system to provide panoramic, wide field-of-view images for easier orientation of anatomy and pathology.
The Technos™ ultrasound imaging system is intended to be used by a physician for diagnostic imaging in cardiac, abdominal, peripheral vascular, fetal, pediatric, small organ, neonatal cephalic, transrectal, transvaginal, intraoperative abdominal, intraoperative peripheral vascular, laparoscopic, adult cephalic, other-urological and musculoskeletal applications.
Device Description
The VPan (View Panoramic) Module is being added to the Technos™ ultrasound imaging system to provide panoramic, wide field-of-view images for easier orientation of anatomy and pathology.
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K Number
K014168Device Name
AU6 (TECHNOS/TECHNOS MP) ULTRASOUND IMAGING SYSTEM (ADDITION OF 3D IMAGING MODE AND MUSCULOSKELETAL INDICATION)
Manufacturer
BIOSOUND ESAOTE, INC.
Date Cleared
2002-04-25
(127 days)
Product Code
IYN, ITX, IYO
Regulation Number
892.1550Why did this record match?
Applicant Name (Manufacturer) :
BIOSOUND ESAOTE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AU6 (Technos/TechnosMP) ultrasound imaging system is intended to be used by a physician for diagnostic imaging in pediatric, small organ, neonatal cephalic, transrectal, transvaginal, intraoperative abdominal, intraoperative peripheral vascular, laparoscopic, adult cephalic and musculoskeletal applications.
Device Description
Not Found
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K Number
K020164Device Name
E-SCAN XQ
Manufacturer
BIOSOUND ESAOTE, INC.
Date Cleared
2002-02-12
(26 days)
Product Code
LNH
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
BIOSOUND ESAOTE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The E-scan XQ is intended for diagnostic nuclear magnetic resonance imaging of the hip, knee, ankle, foot, shoulder, elbow, wrist, hand, calf, thigh, arm and forearm. The device produces transverse, sagittal, coral and oblique cross-sectional images, displaying the internal structure of the limbs and joints being imaged. The images that are produced correspond to the spatial distribution of protons (hydrogen nuclei) that check the magnetic resonance properties and depend upon the MR parameters (spin-lattice relaxation time (T1), spin-spin relaxation time (T2), nuclei density, flow velocity and chemical shift). If interpreted by a medical expert, these images can provide diagnostically useful information.
Device Description
The E-Scan MRI system is substantially equivalent to the currently available E-Scan system cleared via K012728.
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K Number
K012728Device Name
E-SCAN MRI SYSTEM
Manufacturer
BIOSOUND ESAOTE, INC.
Date Cleared
2001-08-29
(14 days)
Product Code
MOS
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
BIOSOUND ESAOTE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The E-scan is intended for diagnostic nuclear magnetic resonance imaging of the hip, knee, ankle, foot, shoulder, elbow, wrist, hand, calf, thigh, arm and forearm. The device produces transverse, sagittal, coronal and oblique cross-sectional images, displaying the internal structure of the limbs and joints being imaged. The images that are produced correspond to the spatial distribution of protons (hydrogen nuclei) that check the magnetic resonance properties and depend upon the MR parameters (spin-lattice relaxation time (T1), spin-spin relaxation time (T2), nuclei density, flow velocity and chemical shift). If interpreted by a medical expert, these images can provide diagnostically useful information.
Device Description
The E-scan is a magnetic resonance diagnostic device. The Multipurpose Flexible Receiving Coil improves the system performance and does not alter the fundamental scientific technology of the cleared device.
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K Number
K010405Device Name
7230 ULTRASOUND IMAGING SYSTEM WITH TEI
Manufacturer
BIOSOUND ESAOTE, INC.
Date Cleared
2001-03-13
(29 days)
Product Code
IYN
Regulation Number
892.1550Why did this record match?
Applicant Name (Manufacturer) :
BIOSOUND ESAOTE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K010057Device Name
MODIFICATION TO ARTOSCAN M
Manufacturer
BIOSOUND ESAOTE, INC.
Date Cleared
2001-02-02
(25 days)
Product Code
LNH
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
BIOSOUND ESAOTE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K001894Device Name
MODIFICATION TO E-SCAN
Manufacturer
BIOSOUND ESAOTE, INC.
Date Cleared
2000-07-06
(15 days)
Product Code
LNH
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
BIOSOUND ESAOTE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K000931Device Name
AU5 ULTRASOUND IMAGING SYSTEM
Manufacturer
BIOSOUND ESAOTE, INC.
Date Cleared
2000-06-08
(78 days)
Product Code
IYN, ITX, IYO
Regulation Number
892.1550Why did this record match?
Applicant Name (Manufacturer) :
BIOSOUND ESAOTE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K000681Device Name
AU5, AU6
Manufacturer
BIOSOUND ESAOTE, INC.
Date Cleared
2000-05-03
(65 days)
Product Code
IYO, ITX, IYN
Regulation Number
892.1560Why did this record match?
Applicant Name (Manufacturer) :
BIOSOUND ESAOTE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K994369Device Name
7250 (MEGAS)
Manufacturer
BIOSOUND ESAOTE, INC.
Date Cleared
2000-02-24
(59 days)
Product Code
IYN
Regulation Number
892.1550Why did this record match?
Applicant Name (Manufacturer) :
BIOSOUND ESAOTE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal, Pediatric, Small Organ (Thyroid, Breast and Testicles), Neonatal Cephalic, Adult Cephalic, Cardiac, Transesophageal, Transrectal, Transvaginal, Peripheral Vascular. Applicable combined modes: B+M+PW+CW+CFM+PD. New indication: Tissue Harmonic Imaging for Cardiac.
Device Description
ESAOTE's 7250 is a compact ultrasound system used to perform non-invasive diagnostic general ultrasound studies. Its primary modes of operation are the following: B-Mode, M-Mode, Doppler, Color Flow Mapping, Harmonic Imaging (TEI) and Amplitude Doppler. The 7250 can be equipped with an LCD Color Display (Portable Configuration) or with a 15" Color Monitor and a cart (Mainframe Configuration). The full alphanumeric keyboard allows complete on-screen data entry of patient information and on-screen annotations. The 7250 can drive annular array, phased, convex and linear array probes. In addition, the 7250 is equipped with a volumetric scan converter and the ability to control simultaneously two independent scan planes. This technological characteristic allows to manage Bi-Scan Probes, to obtain volumetric datasets; these datasets can then be used to display "omni-directional" 2D images (anyplane sectioning) as well as multiple parallel equidistant sections (paraplane sectioning). This Bi-Scan approach is ideal for volume computations through the Simpson rule; specifically, it can be used to measure volumes of irregular structures since it does not require a geometrical assumption. The 7250 is designed for ease of use. The user interface allows the operator to perform an examination quickly and efficiently. Clearly labeled mode selection keys are easily accessed, and the system's "pop-up" menus allow the operator to change parameters with ease. The user may also access special function menus and perform calculations with a minimal number of kev strokes. The 7250 offers a vast selection of calculations and measurements which can be performed quickly and easily. The MOD.7250 is equipped with a 3.5" floppy disk drive to simplify software modifications and provide fast, cost effective system upgrades. This drive (or an optional Optical Disk Drive) can also be used for image storage. Moreover, this unit can store data directly to a Personal Computer via a LAN (Network) port. In addition, the 7250 can be equipped with recording devices, including a S-VHS video recorder and a black-and-white or color printer, which are controlled through the keyboard.
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