What is FDA product code QMW?

A coronary artery disease risk indicator using acoustic heart signals is a device that records heart sounds including murmurs and vibrations to calculate a patient-specific risk of presence of coronary artery disease, as an aid in cardiac analysis and diagnosis.

Cardiovascular › DiagnosticCoronary Artery Disease Risk Indicator From Acoustic Heart Signals

Acarix CADScor Patch

Name: Acarix CADScor Patch
Brand: Acarix CADScor Patch

Acarix CADScor Patch, 20x patch in box. The intended use of the CADScor System is to record heart sounds, murmurs and vibration for calculation of a patient specific score, indicating the…

Registry build 21.09.26

Acarix CADScor Patch, 20x patch in box. 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.

1manufacturer

1catalogue number

1510(k) clearance

Who Else Makes It

Registered in Tianjin. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code QMW
Manufacturer	City	Province	Registered as	Device types
Linxens Healthcare (Tianjin) Co., Ltd.	Jinnan District	Tianjin	Contract manufacturer	7

Record

Regulatory record for Acarix CADScor Patch
Listed by	Acarix A/S, Denmark
FDA product code	QMW
Device type	Coronary Artery Disease Risk Indicator From Acoustic Heart Signals
Device class	Class 2
Regulation	21 CFR 870.1420
510(k)	DEN190047
Record published	2021-07-07

Specifications

Specifications
MRI safety	MR Unsafe
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, expiry date, manufacturing date
Storage	Special storage condition: Store at +10C to +40C; RH >20-80%< RH non-condensing.
Packaging	Box of six of 6

Catalogue Numbers

Catalogue numbers for Acarix CADScor Patch
Catalogue number	Size	Per pack	Status
ACP-1401		20	In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Acarix CADScor System	Acarix A/S	1

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
DEN190047	2020-11-24

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.