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510(k) Data Aggregation
K Number
K130659Device Name
SPEQRT ULTRASOUND SYSTEM
Manufacturer
SIGNOSTICS PTY LTD
Date Cleared
2013-04-03
(22 days)
Product Code
IYN
Regulation Number
892.1550Why did this record match?
Applicant Name (Manufacturer) :
SIGNOSTICS PTY LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SpeqRT ultrasound system is for non-invasive of the human body and is intended for the following applications: Fetal. Abdominal. Pediatric. Musculo-skeletal. Cardiac and Peripheral Vessel. Users must have ultrasound training before using the device. See the attached Indications for Use form for specific imaging modes and applications.
Device Description
The Signostics Ltd SpeqRT ultrasound system is a hand-held, diagnostic ultrasound system with an on-screen display. Its purpose is to acquire ultrasound echo data and display it in B-Mode, M-Mode, or Spectral Doppler) on an LCD display.
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K Number
K090505Device Name
SPEQ ULTRASOUND SYSTEM
Manufacturer
SIGNOSTICS PTY LTD
Date Cleared
2009-05-07
(70 days)
Product Code
IYO
Regulation Number
892.1560Why did this record match?
Applicant Name (Manufacturer) :
SIGNOSTICS PTY LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Speq ultrasound system is for non-invasive imaging of the human body and is intended for the following applications: Fetal, Abdominal, Pediatric, Musculo-skeletal, Cardiac and Peripheral Vessel. Users must have ultrasound training before using the device. See the attached Indications for Use form for specific imaging modes and applications.
Device Description
The Signostics Pty Ltd Speq ultrasound system is a hand-held, diagnostic ultrasound system with an on-screen display. Its purpose is to acquire ultrasound echo data and display it in B-Mode or M-Mode on an LCD display.
Ask a Question
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