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510(k) Data Aggregation
K Number
K161354Device Name
MELODY, Remote Control System for Ultrasound Probe
Manufacturer
Date Cleared
2017-06-12
(392 days)
Regulation Number
892.1560Why did this record match?
Applicant Name (Manufacturer) :
AdEcho Tech
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The MELODY is intended to hold the external ultrasound transducer of cleared ultrasound equipment and provide a remotely-located, expert sonographer the ability to manipulate the transducer in real time through an Internet connection to obtain the ultrasound views required to assess the patient. The MELODY robot frame at the remotely-located patient is prepared and positioned by a trained assistant at the direction of the expert sonographer through a suitable third-party videoconferencing system. Sonograms are transmitted from the patient location from cleared ultrasound equipment through digital telecommunication to the expert sonographer. Indications for the MELODY are tabulated in the Diagnostic Ultrasound Indications table. MELODY may also be used when a physician wants to have a colleague not on-site provide a second opinion.
Device Description
The objective of the MELODY, Remote Control System for Ultrasound Probe, is to allow an expert sonographer to manipulate the transducer of a third-party ultrasonic device remotely and in real time over an internet or similar connection. The remote expert manipulates the precession, nutation, and intrinsic rotation of the transducer, replicating the motions of the hand, to obtain the exact sonography views that he or she requires. The MELODY solves the problem of a lack of imaging experts in isolated areas, e.g., small or rural hospitals or clinics, remote military medical facilities, ships or oil drilling platforms, prison environment, etc.
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