AmCAD UT Detection

Primary DI
04719875621130
Brand
AmCAD UT Detection
Company
AMCAD BIOMED CORPORATION
Model
2.2
Catalog number
UT-0222-1Q
Device description
AmCAD UT Detection is a Windows computer aided detection device intended to assist the medical professionals in analyzing thyroid ultrasound images, acquired from FDA cleared ultrasound systems, with user selected regions of interest. After the initial review of the ultrasound images by the physicians, the device further provides detailed information with quantification and visualization of sonographic characteristics of thyroid nodules. The device is intended for use on ultrasound images of discrete thyroid nodules larger than 1cm, for which a biopsy recommendation is required.
Published
2020-08-27
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LLZSystem, Image Processing, Radiological
QIHAutomated Radiological Image Processing Software

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2
QIHAutomated Radiological Image Processing SoftwareRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180006000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180006000AmCAD-UT Detection 2.2Amcad Biomed Corporation2018-08-31LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719875621130PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719875621130047198756211304719875621130

GMDN Terms#

Term, Definition table
TermDefinition
Ultrasound imaging system application softwareAn 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
656738726
Device count
1
Lot or batch
true
Serial number
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
04719875623004Head & Neck Laser Alignment Tool1.02019-07-31
04719875623103AmCAD UO1.0UO-01022019-07-31

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