Acarix CADScor System

Primary DI
05700002223050
Brand
Acarix CADScor System
Company
Acarix A/S
Model
ACS-1401
Catalog number
ACS-1401 (1x, US-FDA)
Device description
CADScor System (ACS-1401), 1x system package. US-FDA version.The intended use of the CADScor System is to record heart sounds, murmurs and vibration for calculation of a patient specific score, indicating the risk of coronary stenosis, as an aid in cardiac analysis and diagnosis.
Published
2021-07-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QMWCoronary Artery Disease Risk Indicator From Acoustic Heart Signals

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QMWCoronary Artery Disease Risk Indicator From Acoustic Heart SignalsCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN190047000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN190047000CADScor SystemAcarix A/S2020-11-24QMW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05700002223067PackageGS16In Commercial Distribution
05700002223050PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05700002223067057000022230675700002223067
05700002223050057000022230505700002223050

GMDN Terms#

Term, Definition table
TermDefinition
PhonocardiographA device for recording heart sounds at the body surface through the heart's actions which cause vibrations that are transmitted through organs and tissue to the body surface. These are detected by microphones, processed in an electroacoustic transducer, and give sound characteristics in a phonocardiogram. This is used to assess the low frequency sounds (atrial and ventricular gallops), and high frequency sounds (mitral regurgitation and ventricular septal defect). Some also record subsonic frequencies (a few Hertz) considered as vibrations, typically recorded by an apexcardiograph. This method may also be integrated in other electrocardiograph (ECG) devices.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure75 KiloPascal0 KiloPascal
Handling Environment Humidity20 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Special Storage Condition, Specify00Store at +10C to +40C; at RH >20-80%< RH non-condensing.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
9999999999xx@xx.xx

Regulatory Flags#

DUNS number
305132443
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05700002223029Acarix CADScor PatchACP-1401ACP-1401 (20x)2021-07-07
05700002223012Acarix CADScor PatchACP-1401ACP-1401 (20x)2021-07-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05700002223029Acarix CADScor PatchAcarix A/SQMW2021-07-07
05700002223012Acarix CADScor PatchAcarix A/SQMW2021-07-07