# K191738: PageWriter TC20 Cardiograph, PageWriter TC30 Cardiograph, PageWriter TC50 Cardiograph, PageWriter TC70 Cardiograph

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems
- Decided: Sep 29, 2020 after 459 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: 4 generations back to K895520 (1990). 4 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113144: Pagewriter TC 20, 30, 50, 70, Philips Medical Systems (2012) Summary page 4.
- K080999: Pagewriter Cardiograph, Philips Medical Systems (2008) Summary page 4.

## Most influential descendants
- K210560: Page Writer TC20 Cardiograph, Page Writer TC30 Cardiograph, Page Writer TC50 Cardiograph, Page Writer TC70 Cardiograph (2021), 2 descendants of its own
- K241556: Cardiac Workstation (5000); Cardiac Workstation (7000) (2024), 0 descendants of its own
- K221141: PageWriter TC35 Cardiograph (2022), 0 descendants of its own

## Indications for use
Phillips Electrocardiograph PageWriter TC cardiograph (TC20, TC30, TC50, TC70) is intended to acquire multi-channel ECG signals from adult and pediatric patients from body surface ECG electrodes and to record, display, analyze and store these ECG signals for review by the user. It is to be used in healthcare facilities by trained healthcare professionals. Analysis of the ECG signals is accomplished with algorithms that provide measurements, data presentations, graphical presentations and interpretations for review by the user. The interpreted ECG with measurements and interpretive statements is offered to the clinician on an advisory basis only. It is to be used in conjunction with the clinician's knowledge of the patient, the results of the physical examination, the ECQG tracings, and other clinical findings. A qualified physician is asked to over read and validate (or change) the computer generated ECG interpretation.

Source page: https://510kreport.com/device/K191738
Methodology: https://510kreport.com/methodology