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 System

Name: Acarix CADScor System
Brand: Acarix CADScor System

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…

Registry build 21.09.26

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.

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 System
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
Prescription	Prescription only
Label carries	serial number
Storage	Handling environment humidity 20 to 80 % RH; Special storage condition: Store at +10C to +40C; at RH >20-80%< RH non-condensing.; Handling environment temperature 10 to 40 °C; Handling environment atmospheric pressure from 75 KiloPascal
Packaging	Box of six of 6

Catalogue Numbers

Catalogue numbers for Acarix CADScor System
Catalogue number	Size	Status
ACS-1401		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Acarix CADScor Patch	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.