AmCAD UO

Primary DI
04719875623103
Brand
AmCAD UO
Company
AMCAD BIOMED CORPORATION
Model
1.0
Catalog number
UO-0102
Device description
AmCAD UO is a PC based, self contained, non invasive image analysis software application for reviewing the pharyngeal/upper airway ultrasonic image acquired from an FDA cleared ultrasound system. The software is designed to support visualization and quantification of the airway sonographic characteristics. The software also provides tools for manual or interactive selection of Region of Interest to allow for analysis of the airway in terms of its size, position and enhancement pattern. This analysis provides information for physician’s evaluation and monitoring of the airway state.
Published
2019-07-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LLZSystem, Image Processing, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180867000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180867000AmCAD-UOAmcad Biomed Corporation2018-12-28LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719875623103PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719875623103047198756231034719875623103

GMDN Terms#

Term, Definition table
TermDefinition
Ultrasound imaging system application software"An individual software program or group of programs, routines or algorithms that add specific image processing and/or analysis capabilities to a diagnostic ultrasound system configuration. A basic set of applications programs and routines are included with such computer-controlled imaging systems and they can be upgraded to correct programming errors or to add new system capabilities. Some applications software programs or program packages must be combined with specific hardware or firmware configurations in order to function as intended. Applications program packages are typically identified by a proprietary name and ""version"" or ""upgrade"" number."

Regulatory Flags#

DUNS number
656738726
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04719875622007AmCAD-US1.0US-01012026-04-14
04719875621000AmCAD UT Detection2.2UT-02222019-07-31
04719875621017AmCAD UT Detection2.2UT-0222-D2019-07-31
04719875621024AmCAD UT Detection2.2UT-0222-5002019-07-31
04719875621086AmCAD UT Detection2.2UT-0222-1Y2019-07-31
04719875621093AmCAD UT Detection2.2UT-0222-10002019-07-31
04719875621109AmCAD UT Detection2.2UT-0222-502019-07-31
04719875621116AmCAD UT Detection2.2UT-0222-KOL2019-07-31
04719875621123AmCAD UT Detection2.2UT-0222-1P2019-07-31
04719875621130AmCAD UT Detection2.2UT-0222-1Q2020-08-27
04719875623004Head & Neck Laser Alignment Tool1.02019-07-31

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