FDA.reportPublic FDA data

Neo Medical

Primary DI
04719890960269
Brand
Neo Medical
Company
Aco Healthcare Co., Ltd.
Model
neo L154
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
IYNSystem, Imaging, Pulsed Doppler, Ultrasonic
IYOSystem, Imaging, Pulsed Echo, Ultrasonic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
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
04719890960269PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719890960269047198909602694719890960269

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
04719890960276Neo Medicalneo L1872024-09-09
04719890960283Neo Medicalneo P422024-09-09
04719890960054Aco Smartcareneo L1542024-05-13
04719890960061Aco Smartcareneo L1872024-05-13
04719890960078Aco Smartcareneo P422024-05-13
04719890960047Aco Smartcareneo C622024-05-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08056304455826MyLabC25ESAOTE SPAIYO2025-12-10
08056304455833MyLabC30ESAOTE SPAIYO2025-12-10
08056304455017MyLabA50ESAOTE SPAIYO2025-07-07
08056304455215MyLabE85ESAOTE SPAIYO2025-07-07
08056304455307MyLabA70ESAOTE SPAIYO2025-07-07
08056304455437MyLabA50ESAOTE SPAIYO2025-07-07
08056304455451MyLabA70ESAOTE SPAIYO2025-07-07
08056304455635MyLabE80ESAOTE SPAIYO2025-07-07
08056304455642MyLabE85ESAOTE SPAIYO2025-07-07
08056304455628MyLabE80ESAOTE SPAIYO2024-03-29
08056304454980MyLabX90ESAOTE SPAIYO2023-12-14
08056304455031MyLabOmega eXPESAOTE SPAIYN2023-12-14
08056304455031MyLabOmega eXPESAOTE SPAIYO2023-12-14
08056304454676MyLabX9ESAOTE SPAIYN2023-06-13
G055ABMVIVM031VIVACE ULTRAAesthetics Biomedical, Inc.IYO2022-12-30
G055ABMVIVM041VIVACE ULTRAAesthetics Biomedical, Inc.IYO2022-12-30
G055ABMVIVM071VIVACE ULTRAAesthetics Biomedical, Inc.IYO2022-12-30
G055ABMVIVM081VIVACE ULTRAAesthetics Biomedical, Inc.IYO2022-12-30
G055ABMVIVM111VIVACE ULTRAAesthetics Biomedical, Inc.IYO2022-12-30
G055ABMVIVM121VIVACE ULTRAAesthetics Biomedical, Inc.IYO2022-12-30
G055ABMVIVU010VIVACE ULTRAAesthetics Biomedical, Inc.IYO2022-12-30
G055ABMVIVM010VIVACE ULTRAAesthetics Biomedical, Inc.IYO2022-12-30
G055ABMVIVM020VIVACE ULTRAAesthetics Biomedical, Inc.IYO2022-12-30
G055ABMVIVM050VIVACE ULTRAAesthetics Biomedical, Inc.IYO2022-12-30
G055ABMVIVM060VIVACE ULTRAAesthetics Biomedical, Inc.IYO2022-12-30
G055ABMVIVM090VIVACE ULTRAAesthetics Biomedical, Inc.IYO2022-12-30
G055ABMVIVM100VIVACE ULTRAAesthetics Biomedical, Inc.IYO2022-12-30
G055ABMVIVR010VIVACE ULTRAAesthetics Biomedical, Inc.IYO2022-12-30
G055ABMVIVS010VIVACE ULTRAAesthetics Biomedical, Inc.IYO2022-12-30
G055ABMVIVS020VIVACE ULTRAAesthetics Biomedical, Inc.IYO2022-12-30