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DEVICE DETAILS

NAME OF DEVICEACO APACHE ULTRASOUND
ESTABLISHMENT NAMEMARKETECH INTERNATIONAL SDN BHD
ROLE OF ESTABLISHMENTAUTHORIZED REPRESENTATIVE
REGISTRATION NOGB6562126-227943
BRAND NAMEACO SMARTCARE
MEDICAL DEVICE CATEGORYMD 1100 - GENERAL ACTIVE MEDICAL DEVICES
DEVICE GROUPING TYPEFAMILY
DEVICE DESCRIPTIONThe Aco Apache Ultrasound System is a portable color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. It 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, Color Doppler, Power Doppler, PW Mode, and a combination of these modes. Aco Apache Ultrasound System in this submission covers seven types of transducers, neo C62, neo L154, neo L187, and neo P42. The system consists of two primary components: the handheld Apache Probe and Apache App. The probe transmits and receives ultrasound signals. It sends the processed ultrasound data to Apache App through wireless data transmission for rendering of ultrasound imaging. The Apache App provides the interface for user control and display.
DEVICE INTENDED PURPOSEThe system is intended for general diagnostic ultrasound imaging and fluid flow analysis.
VALIDITY DATE OF REGISTRATION06/03/2026 - 05/03/2031

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