Search Results
Found 1 results
510(k) Data Aggregation
K Number
K211232Device Name
Apache Ultrasound System
Manufacturer
Date Cleared
2021-06-25
(63 days)
Regulation Number
892.1550Why did this record match?
Applicant Name (Manufacturer) :
Aco Healthcare Co,. Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Apache Ultrasound System is intended for diagnostic ultrasound imaging and fluid flow analysis in the following applications: Abdominal, Fetal/Obstetric, Gynecological, Fetal Echo, Musculo-skeletal (conventional and superficial), Small Organ (including breast, scrotum, thyroid), Peripheral Vessel, Carotid, Urology, and Pediatric. The system provides diagnostic ultrasound imaging in B, Color Doppler, M, PW and Combined (B+M; B+CD) modes. The clinical environments where the system can be used include physician offices, clinics, and clinical point-of-care for diagnosis of patients except environments where intensity of electromagnetic disturbances is high. The Apache Ultrasound System is a portable ultrasound system intended for use in environments where is provided by trained healthcare professionals.
Device Description
The Apache Ultrasound System is a portable color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications through wireless communication with an off-the-shelf (OTS) mobile device. This system is a general purpose, software controlled, diagnostic ultrasound system. Its basic function is to acquire ultrasound data and display the image in B-Mode, M-Mode, PW mode and Color Doppler or a combination of these modes.
The Apache Probe processes the ultrasound signal and transfers real-time scan image data to the Apache App through the wireless connection with the mobile device. The 64-channel beamforming architecture of the probe maximizes the utility of all imaging transducer elements to enhance the diagnostic utility and confidence provided by the system. The Apache App provides the interface for mode/setting control and image display, acquisition, and storage functions. The Apache App is compatible with Android and iOS based mobile devices. Verified devices include Samsung Galaxy Tab S6, Samsung Galaxy Tab S7, Samsung Galaxy S10, Samsung Galaxy S21, Google Pixel 4, HTC U11, LG G85 ThinQ, iPhone 11, iPhone 12, iPad Pro 11-inch (Gen2), and iPad Air (Gen4).
The clinical environments where the system can be used include physician offices, clinics, hospitals, and clinical point-of-care for diagnosis of patients except environments where intensity of electromagnetic disturbances is high.
The Apache Ultrasound System is a portable ultrasound system intended for use in environments where healthcare is provided by trained healthcare professionals.
Ask a Question
Ask a specific question about this device
Page 1 of 1