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510(k) Data Aggregation
K Number
K230511Device Name
K3900 Ultrasound Imaging System
Manufacturer
Date Cleared
2023-10-25
(243 days)
Regulation Number
892.1560Why did this record match?
Applicant Name (Manufacturer) :
MAUI Imaging
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The K3900 Ultrasound Imaging System is intended for use by a qualified healthcare personnel in environments where healthcare is provided for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); and Intraoperative (abdominal, thoracic and vascular).
Device Description
The K3900 Ultrasound Imaging System ("K3900") is a Track 3 general purpose ultrasound imaging system. The device generates and collects ultrasonic pulsed echo data via a transducer that is then digitized for further processing. The processing includes beamforming, image processing, and image optimization that then outputs an ultrasound image. This image may be displayed on a tablet or common displays through HDMI for general purpose radiological evaluation. The K3900 consists of an ultrasound transducer, a processing unit that manages the transducer and all data processing, and a tablet that provides the user interface to operate the device, view and analyze the ultrasound dataset, and manage patient study sessions.
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