# K070614: Corscreen

- Pathway: 510(k) (Traditional)
- Applicant: Viasys Healthcare GmbH
- Decided: May 4, 2007 after 60 days
- Product code: DPS (Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K002074 (2000). 1 ancestor in all.
12 later devices descend from it; 2 cite it directly.
1 of 14 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002074: AB Cardiette Daedalus View Base and AB Cardiettte Daedalus View Hes, H&C Medical Devices Spa (2000) Summary page 2.

## Most influential descendants
- K080734: Flowscreen, Flowscreen/Corscreen, Flowscreen CT (2008), 10 descendants of its own
- K082539: Masterscope, Masterscope Ecg, Masterscope CT (2008), 9 descendants of its own
- K091505: COR12+ (2009), 6 descendants of its own
- K150810: Vyntus / SentrySuite Product Line (2015), 5 descendants of its own
- K202754: MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSU (2021), 1 descendant of its own

## Indications for use
CorScreen is an active medical device and is intended for measuring a 3/6- or 12-channel surface electrocardiogram (ECG) of a patient. The acquired ECG can be recorded and displayed on a screen or printed on paper. 12-channel ECGs are analysed automatically and suggestions for the interpretation of the 12-channel ECG can be made by the software. CorScreen can be used for non interpretive applications for patients with an age of 4 years and older and a weight of 20 kg or higher. CorScreen is intended for use in routine ECG recording by trained physicians in the office or hospital. CorScreen is not intended for intracardial use. Automatic interpretation of the ECG is not possible for pediatric patients with an age below 16 years and for pacemaker patients. The interpretation software is intended to support the physician in evaluating the ECG in terms of morphology and rhythm. Intended use is equivalent to the intended use of the predicate device AB Cardiette Daedalus View Hes. A qualified physician has to reassess all CorScreen measurements. An interpretation by CorScreen is only significant if it is considered in connection with other clinical findings. ECG interpretation statements made by the CorScreen represent partial qualitative and quantitative information on the patient's cardiovascular condition and no therapy or drugs can be administered based solely on the interpretation statements. Federal U.S. law restricts this device to sale by or on the order of a physician.

Source page: https://510kreport.com/device/K070614
Methodology: https://510kreport.com/methodology