# K093172: Quantitative Electrocardiographic Detector (Qed 1000)

- Pathway: 510(k) (Traditional)
- Applicant: Dynacardia, Inc.
- Decided: Jan 20, 2010 after 104 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: 7 generations back to K921669 (1993). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080999: Pagewriter Cardiograph, Philips Medical Systems (2008) Summary page 1.
- K073625: Modification to: Mac 5500 Resting Ecg Analysis System, Ge Healthcare Systems Information Technologies (2008). Our reading of the summary gave K073825, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “MAC 5500”.

## Indications for use
The intended use of the QED 1000 is to record 12-lead ECG signals from adult patients from body surface ECG electrodes. This device can acquire, display, record, and store these ECG signals for review by the user. The QED 1000 is intended to be used in healthcare facilities by trained healthcare professionals. A qualified physician must over-read all computer-generated tracings. The QED 1000 is designed for use by a qualified physician to evaluate the electrocardiogram of adult patients as part of clinical diagnosis.

Source page: https://510kreport.com/device/K093172
Methodology: https://510kreport.com/methodology