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510(k) Data Aggregation
K Number
K153620Device Name
Enovare Ultrasound System
Manufacturer
Date Cleared
2016-05-05
(139 days)
Regulation Number
892.1560Why did this record match?
Applicant Name (Manufacturer) :
OREON TECHNOLOGIES INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Enovare system's ultrasound scanner connected with a probe enables real time diagnostic ultrasound imaging for Bmode, Tissue and Contrast Harmonic Imaging, PWD, Power Doppler and combined mode imaging. Signal Analysis and display. Guidance of biopsy and therapy needles, geometrical measurements and calculation of parameters. The system offers optional probes each type optimized to image structure and orientation of tissues during specific clinical applications. These include general Abdominal, Intraoperative, Cardiac, Neurosurgery, Transrectal, Small organs, Urological, Transvaginal, Musculoskeletal.
Device Description
The Enovare supports the following scanning modes and combinations thereof: B-mode (incl. Tissue Harmonic Imaging), PWD mode, CFM mode, Amplitude (Power) Doppler mode.
The system consists of:
- system cart
- keyboard ●
- ultrasound probe(s) ●
- LCD monitor ●
The system can perform simple geometric measurements and perform calculations in the vascular and urology areas.
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