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510(k) Data Aggregation
K Number
K171594Device Name
Accuro
Manufacturer
Rivanna Medical, LLC
Date Cleared
2017-10-20
(142 days)
Product Code
IYO, ITX
Regulation Number
892.1560Why did this record match?
Applicant Name (Manufacturer) :
Rivanna Medical, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Accuro is intended for diagnostic ultrasound imaging of the human body in the following clinical applications: Abdominal, Musculoskeletal (conventional and superficial), Cardiac, Peripheral Vascular, Small Organs (e.g. thyroid, breast), and Pediatrics. A typical examination using the Accuro is guidance of neuraxial anesthesia.
Device Description
The Accuro is a hand-held device that features real-time B-mode ultrasound imaging only. Additional features include a compact size and a simple user interface.
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K Number
K132736Device Name
ACCURO 3000 ULTRASOUND SCANNER
Manufacturer
RIVANNA MEDICAL, LLC
Date Cleared
2014-03-11
(189 days)
Product Code
IYO, ITX
Regulation Number
892.1560Why did this record match?
Applicant Name (Manufacturer) :
RIVANNA MEDICAL, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Accuro 3000 ultrasound scanner is intended for diagnostic ultrasound imaging of the human body in the following clinical applications: Abdominal, Musculoskeletal (Conventional and superficial), Cardiac, Peripheral vascular. A typical examination using the Accuro 3000 is guidance of neuraxial anesthesia.
Device Description
The Accuro 3000 Ultrasound Imaging Device is a hand-held device that features real-time B-mode ultrasound imaging only. Additional features include a compact size and a simple user interface.
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