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Pulsenmore ES Type iOS

Ultrasound imaging system for acquiring images at home by lay users

Details

Device typeHand-held ultrasound imaging system, body-surface: A battery-powered, hand-held device/device assembly designed to be placed over the external body surface for collection, display, and analysis of ultrasound information during a variety of ultrasound imaging procedures (i.e., non-dedicated); it may in addition be intended to be used with a sterile cover for intraoperative imaging. It consists of a flat- or concave-lensed ultrasound transducer and includes an integrated image processing system; it may include an integrated display or be intended to wirelessly transmit images to an off-the-shelf device (e.g., smartphone, tablet) with dedicated software installed. It is not designed to be inserted into the vagina or rectum.

FDA categoryUltrasound Imaging System For Acquiring Images At Home By Lay Users

Device ID07290018579039

Catalog number400-0003

AvailabilityPrescription

MRI safetyLabeling does not contain MRI Safety Information

Contact

No contact is listed for this device.

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