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510(k) Data Aggregation
K Number
K121063Device Name
VIVID S5 DIAGNOSTIC ULTRASOUND SYSTEM, VIVID S6 DIAGNOSTIC ULTRASOUND SYSTEM
Manufacturer
GE MEDICAL SYSTEM ISRAEL LTD.
Date Cleared
2012-08-21
(137 days)
Product Code
IYN, ITX, IYO, LLZ
Regulation Number
892.1550Why did this record match?
Applicant Name (Manufacturer) :
GE MEDICAL SYSTEM ISRAEL 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/Obstetrics; Abdominal/Gynecology; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal; Transrectal; Transvaginal; and Intraoperative (abdominal, thoracic, and vascular).
Device Description
The Vivid S5 and Vivid S6 are mobile ultrasound consoles having a wide assortment of electronic array transducers intended primarily for echocardiography with additional capability in vascular and general ultrasound imaging. Its intuitive user interface, high level of auto-optimization along with significantly reduced size and weight make it readily maneuverable, efficient and easy to use.
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K Number
K121062Device Name
VIVID I DIAGNOSTIC ULTRASOUND SYSTEM, VIVID Q DIAGNOSTIC ULTRASOUND SYSTEM
Manufacturer
GE MEDICAL SYSTEM ISRAEL LTD.
Date Cleared
2012-08-17
(133 days)
Product Code
ITX, IYN, IYO, LLZ
Regulation Number
892.1570Why did this record match?
Applicant Name (Manufacturer) :
GE MEDICAL SYSTEM ISRAEL 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/Obstetrics; Abdominal/Gynecology; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal; Transrectal; Transvaginal; and Intraoperative (abdominal, thoracic, and vascular).
The device may include EchoPilot reporting software which provides guidance to support the quality of the echocardiography examination and report. It compares patient data, user entered clinical data and measurements to generally accepted guidelines and studies, and helps to identify mismatches, inconsistencies and unusual or missing data. It can generate a preliminary data analysis that can be used as basis for the examination report.
Device Description
The Vivid i and Vivid q are mobile ultrasound consoles having a wide assortment of electronic array transducers intended primarily for echocardiography with additional capability in vascular and general ultrasound imaging. Its intuitive user interface, high level of auto-optimization along with significantly reduced size and weight make it readily maneuverable, efficient and easy to use.
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K Number
K102393Device Name
VIVID S5 DIAGNOSTIC ULTRASOUND SYSTEM; VIVID S6 DIAGNOSTICULTRASOUND SYSTEM
Manufacturer
GE MEDICAL SYSTEM ISRAEL LTD.
Date Cleared
2010-11-05
(74 days)
Product Code
IYO, ITX, IYN
Regulation Number
892.1560Why did this record match?
Applicant Name (Manufacturer) :
GE MEDICAL SYSTEM ISRAEL 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/Obstetrics; Abdominal/Gynecology; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal; Transrectal; Transvaginal; and Intraoperative (abdominal, thoracic, and vascular).
Device Description
The Vivid S5 and Vivid S6 are mobile ultrasound consoles having a wide assortment of electronic array transducers intended primarily for echocardiography with additional capability in vascular and general ultrasound imaging. Its intuitive user interface, high level of auto-optimization along with significantly reduced size and weight make it readily maneuverable, efficient and easy to use.
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K Number
K102388Device Name
VIVID I DIAGNOSTIC ULTRASOUND SYSTEM
Manufacturer
GE MEDICAL SYSTEM ISRAEL LTD.
Date Cleared
2010-11-04
(73 days)
Product Code
IYN, ITX, IYO
Regulation Number
892.1550Why did this record match?
Applicant Name (Manufacturer) :
GE MEDICAL SYSTEM ISRAEL LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Ultrasound imaging, measurement and analysis of the human body as follows: Abdominal/GYN; Urology; Fetal/OB; Small Organ (breast, testes, thyroid); Pediatric; Neonatal & Adult Cephalic; Cardiac (adult & pediatric); Peripheral Vascular; Musculo-skeletal (conventional & superficial); Transesophageal; Intraoperative (abdominal, thoracic and PV); Transvaginal and Transrectal, Intra-cardiac and intra-luminal applications.
Device Description
The Vivid-i and Vivid-q are compact and portable diagnostic ultrasound systems with integrated keyboard, fold-up LCD type display and interchangeable electronic-array transducers. They have an overall size approximately 36 cm wide, 31.5 cm deep and 6 cm high in transport configuration and provide digital acquisition, processing and display capability. The user interface includes a computer keyboard, an intuitive layout of specialized controls, color GUI display and Doppler audio.
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