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Found 3 results
510(k) Data Aggregation
K Number
K092140Device Name
GE VIVID I DIAGNOSTIC ULTRASOUND, GE VIVID Q DIAGNOSTIC ULTRASOUND
Manufacturer
GE MEDICAL SYSTEMS ISRAEL, ULTRASOUND, LTD.
Date Cleared
2009-08-21
(37 days)
Product Code
IYO, ITX, IYN
Regulation Number
892.1560Why did this record match?
Applicant Name (Manufacturer) :
GE MEDICAL SYSTEMS ISRAEL, ULTRASOUND, 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; 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; Intraoperative (abdominal, thoracic, and vascular), Intra-cardiac and Intra-luminal.
Device Description
The GE Vivid-i and Vivid-q is compact and portable diagnostic ultrasound system with integrated keyboard, fold-up LCD type display and interchangeable electronic-array transducers. It has an overall size approximately 36 cm wide, 31.5 cm deep and 6 cm high in transport configuration and provides 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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K Number
K092079Device Name
MODIFICATION TO GE VIVID S5 AND S6 DIAGNOSTIC ULTRASOUND
Manufacturer
GE MEDICAL SYSTEMS ISRAEL, ULTRASOUND, LTD.
Date Cleared
2009-08-06
(28 days)
Product Code
IYN, ITX, IYO
Regulation Number
892.1550Why did this record match?
Applicant Name (Manufacturer) :
GE MEDICAL SYSTEMS ISRAEL, ULTRASOUND, 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/GYN; 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; Transvaginal; and Intraoperative (abdominal, thoracic, and vascular).
Device Description
The GE 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 autooptimization along with significantly reduced size and weight maneuverable, efficient and easy to use.
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K Number
K082374Device Name
VIVID I AND VIVID Q
Manufacturer
GE MEDICAL SYSTEMS ISRAEL, ULTRASOUND, LTD.
Date Cleared
2008-09-02
(15 days)
Product Code
IYN, ITX, IYO
Regulation Number
892.1550Why did this record match?
Applicant Name (Manufacturer) :
GE MEDICAL SYSTEMS ISRAEL, ULTRASOUND, 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; 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; Transvaginal; Intraoperative (obdominal, thoracic, and vascular), Intra-cardiac and Inra-luminal.
Device Description
The GE Vivid-i and Vivid-q is compact and portable diagnostic ultrasound system with integrated keyboard, fold-up LCD type display and interchangeable electronic-array transancess. It has an overall size approximately 36 cm wide, 31.5 cm deep and 6 cm high in transport configuration and provides 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.
Ask a Question
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