# K082539: Masterscope, Masterscope Ecg, Masterscope CT

- Pathway: 510(k) (Traditional)
- Applicant: Cardinal Health Germany 234 GmbH
- Decided: Dec 2, 2008 after 91 days
- Product code: BTY (Calculator, Predicted Values, Pulmonary Function)
- Device class: 2
- Regulation: 21 CFR 868.1890
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K002074 (2000). 5 ancestors in all.
9 later devices descend from it; 3 cite it directly.
1 of 15 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071753: Masterscreen Pneumo & Masterscope, Viasys Healthcare GmbH (2007) Summary page 2.
- K080734: Flowscreen, Flowscreen/Corscreen, Flowscreen CT, Viasys Healthcare GmbH (2008) Summary page 2.

## Most influential descendants
- 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
- K181524: Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART, Vyntus ONE PFT only with adjustable CART (2018), 1 descendant of its own
- K223629: SpiroSphere, SpiroSphereECG, CardioSphere (2024), 0 descendants of its own

## Indications for use
The MasterScope / MasterScope ECG is intended to be used for measurement and data collection of lung function parameters. The system performs cooperation-dependent flow volume measurements. Mostly it will be used for COPD and Asthma patients. In addition it 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 the screen or printed on paper. 12-channel ECG's are analysed automatically and suggestions for the interpretation of the 12-channel ECG can be made by the software. MasterScope / MasterScope ECG 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. MasterScope / MasterScope ECG is intended for use in routine ECG recording by trained physicians in the office or hospital. MasterScope / MasterScope ECG 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. MasterScope CT (Clinical Trial version) incorporates the identical measurements. In addition it offers workflow control elements to restrict the use of the equipment (e.g. individual access rights are defined for different user roles like investigator, doctor, study nurse, trainer and service personnel). The interpretation software is intended to support the physician in evaluation the ECG in terms of morphology and rhythm. A qualified physician has to reassess all MasterScope / MasterScope ECG measurements. An interpretation by MasterScope / MasterScope ECG is only significant if it is considered in connection with other clinical findings. ECG interpretation statements made by the MasterScope / MasterScope ECG 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. The MasterScope / MasterScope ECG / MasterScope CT is powered from 100 - 240V / 50 - 60Hz wall outlets. No energy is transferred to the patient.

Source page: https://510kreport.com/device/K082539
Methodology: https://510kreport.com/methodology