# K042782: Seer MC

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems Information Technologies
- Decided: Sep 2, 2005 after 331 days
- Product code: MLO (Electrocardiograph, Ambulatory, With Analysis Algorithm)
- Device class: 2
- Regulation: 21 CFR 870.2800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K911097 (1991). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K882818: SEER, Marquette Electronics, Inc. (1989) Summary page 1.
- K021373: H12+Holter Recorder, Mortara Instrument, Inc. (2002) Summary page 1.

## Most influential descendants
- K142468: Stealth Monitor, Stealth Docking Cable, Stealth DSD Software Installation Disk, Stealth System (2015), 0 descendants of its own

## Indications for use
The SEER MC Ambulatory Digital Analysis Recorder is intended to provide ambulatory ECG signal and automated analysis of the recorded ECG data. Results of the automated analysis, when used in conjunction with an ECG review system, are intended to assist the physician in the interpretation of the recorded data. This information is not intended to serve as a substitute for the physician overread of the recorded ECG data. The SEER MC can collect and store up to 48 hours of continuous 2 or 3 channels of ambulatory ECG data. In addition, the SEER MC can record and analyze 12-lead ambulatory ECG data for definition of morphology shape and measurements, heart rate, rhythm, and ST segment trending. The SEER MC is intended for use on adult and pediatric (greater than 10Kg) patients in a clinical setting by qualified medical personnel. The SEER MC in its 2 or 3 channel mode of operation detects the following: normal beats, ventricular beats, supraventricular beats, paced beats and artifact. This information, in conjunction with an ECG review system, documents tile following: fastest and slowest heart rate, runs of ventricular beats, runs of supraventricular beats, pauses, ST segment changes, areas of atrial fibrillation, percentage of paced beats, prolonged QT, T-Wave Alternans, Heart Rate Turbulence, Heart Rate Variability and ECG strips associated with patient events and/or symptoms. The SEER MC in its 12-lead mode of operation, in conjunction with a ECG Review system, documents the aforementioned information and also measures and trends the following 12 lead parameters: PR interval, QT ii'u:,ral, QRS duration, ST measurements at J point plus 40, 60 and 80 mseconds for all 12 leads and displays the Ventricular rate, and P, R and T axis for each 12-lead segment. The SEER MC is not intended to be used as a substitute for a standard, diagnostic-quality 12-lead electrocardiograph.

Source page: https://510kreport.com/device/K042782
Methodology: https://510kreport.com/methodology