Neo Medical

Primary DI
04719890960283
Brand
Neo Medical
Company
Aco Healthcare Co., Ltd.
Model
neo P42
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 UserNeo 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
Published
2024-09-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ITXTransducer, Ultrasonic, Diagnostic
IYNSystem, Imaging, Pulsed Doppler, Ultrasonic
IYOSystem, Imaging, Pulsed Echo, Ultrasonic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITXTransducer, Ultrasonic, DiagnosticRadiology2
IYNSystem, Imaging, Pulsed Doppler, UltrasonicRadiology2
IYOSystem, Imaging, Pulsed Echo, UltrasonicRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K231509000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231509000Aco Apache Ultrasound SystemAco Healthcare Co., Ltd.2023-10-24IYN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719890960283PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719890960283047198909602834719890960283

GMDN Terms#

Term, Definition table
TermDefinition
Hand-held ultrasound imaging system, body-surfaceA 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
408-278-9300service@neomedicalusa.com

Regulatory Flags#

DUNS number
658742955
Device count
1
DM exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04719890960252Neo Medicalneo C622024-09-09
04719890960269Neo Medicalneo L1542024-09-09
04719890960276Neo Medicalneo L1872024-09-09
04719890960054Aco Smartcareneo L1542024-05-13
04719890960061Aco Smartcareneo L1872024-05-13
04719890960078Aco Smartcareneo P422024-05-13
04719890960047Aco Smartcareneo C622024-05-06

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