Aco Smartcare

GUDID 04719890960054

The Aco 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, Color Doppler mode, Power Doppler mode, PW mode or a combination of these modes.

Aco Healthcare Co., Ltd.

Hand-held ultrasound imaging system, body-surface

• Primary Device ID: 04719890960054
• NIH Device Record Key: d9e3c40a-1b1a-439a-9895-0e8020cd0c12
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aco Smartcare
• Version Model Number: neo L154
• Company DUNS: 658742955
• Company Name: Aco Healthcare Co., Ltd.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04719890960054 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231509

FDA Product Code

• IYN: System, Imaging, Pulsed Doppler, Ultrasonic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-05-21
• Device Publish Date: 2024-05-13

On-Brand Devices [Aco Smartcare]

• 04719890960047: The Aco Apache Ultrasound System is a portable color ultrasound imaging system, capable of produ
• 04719890960078: The Aco Apache Ultrasound System is a portable color ultrasound imaging system, capable of produ
• 04719890960061: The Aco Apache Ultrasound System is a portable color ultrasound imaging system, capable of produ
• 04719890960054: The Aco Apache Ultrasound System is a portable color ultrasound imaging system, capable of produ