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510(k) Data Aggregation
K Number
K013142Device Name
DIASUS
Manufacturer
DYNAMIC IMAGING LTD.
Date Cleared
2001-10-05
(15 days)
Product Code
IYO
Regulation Number
892.1560Why did this record match?
Applicant Name (Manufacturer) :
DYNAMIC IMAGING LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Diasus Ultrasound Imaging system is intended for performing no-invasive diagnostic general ultrasound studies. Such uses include the following; Abdominal, Cardiac, Paediatric, Small organs including, Thyroid, Parathyroid, Breast and Testes, Neonatal / adult cephalic, Peripheral vascular, and Conventional / Superficial Musculoskeletal.
Diagnostic Ultrasound imaging of the human body as follows: Abdominal, Pediatric, Small Organ (Thyroid, Parathyroid, Breast and Testes in adult, paediatric and neonatal patients), Neonatal Cephalic, Adult Cephalic, Peripheral Vascular, Musculo-skeletal Conventional, Musculo-skeletal Superficial. Includes imaging for needle guidance.
Device Description
Diagnostic Ultrasound System with Accessories
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