Neo Medical

Basic Information

• Brand Name: Neo Medical
• Primary DI: 04719890960252
• Version / Model: neo C62
• Company Name: Aco Healthcare Co., Ltd.
• Labeler DUNS: 658742955
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-09-09
• Public Version: 1
• Public Version Date: 2024-09-17
• Public Version Status: New
• Public Device Record Key: 50bac204-21db-4050-9552-30dbf6f72d5d

Device Description

Neo Medical 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, FAST/EFAST, Lung, Ocular, Transcranial, Nerve, Bladder, Cardiac (Pediatric and Adult) and Pediatric. The system provides diagnostic ultrasound imaging in B, Color Doppler, M, Power Doppler, PW Doppler and Combined (B+M; B+CD; B+PD) modes. Intended User Neo Medical Ultrasound System is a portable ultrasound system intended for use in environments where healthcare is provided by trained healthcare professionals. 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. Neo Medical System is a portable ultrasound system intended for use in environments where healthcare is provided by trained healthcare

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	892.1550	2
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	892.1560	2
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	892.1570	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60924	Hand-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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04719890960252	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K231509	000