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510(k) Data Aggregation
K Number
K160420Device Name
SpeqT
Manufacturer
Date Cleared
2016-03-21
(34 days)
Regulation Number
892.1560Why did this record match?
Applicant Name (Manufacturer) :
Signostics Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The SpeqT is for non-invasive imaging of the human body and is intended for the following applications: Abdominal, Musculoskeletal, Pediatric, and Small Organ. Users must have ultrasound training for abdominal, musculoskeletal, pediatric, and small organ imaging.
The SpeqT can also be used to obtain an image of the bladder that is used to automatically determine bladder volume.
Device Description
The Signostics Ltd SpecT 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, on an off-the-shelf display. Automated bladder volume measurements are supported.
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K Number
K152250Device Name
SpeqRT
Manufacturer
Date Cleared
2015-09-03
(24 days)
Regulation Number
892.1550Why did this record match?
Applicant Name (Manufacturer) :
Signostics Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The SpeqRT 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 Ltd SignosRT is a hand-held, diagnostic ultrasound system with an onscreen display. Its purpose is to acquire ultrasound echo data and display it in B-Mode, M-Mode, or Spectral Doppler (PW Doppler) on an LCD display.
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