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510(k) Data Aggregation
K Number
K100598Device Name
PENRITH ELETTRA ULTRASOUND SYSTEM
Manufacturer
PENRITH CORPORATION
Date Cleared
2010-11-19
(261 days)
Product Code
IYN, ITX, IYO
Regulation Number
892.1550Why did this record match?
Applicant Name (Manufacturer) :
PENRITH CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Elettra Ultrasound System is intended for diagnostic imaging or fluid flow analysis of the human body including: Fetal, Abdominal, Intraoperative, Intraoperative Neurological, Pediatric, Small Organ, Neonatal Cephalic, Cardiac, Peripheral Vessel, Musculoskeletal (Conventional), Musculoskeletal (Superficial).
Device Description
The Penrith Elettra is a compact diagnostic ultrasound device. It includes a system console housing electronic circuitry, a video display, power supply, and user controls. This connects to the transducers and together these generate the ultrasound image.
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