# K970902: Medilog FD4

- Pathway: 510(k) (Traditional)
- Applicant: Oxford Instruments Medical Systems
- Decided: May 5, 1997 after 55 days
- Product code: DSH (Recorder, Magnetic Tape, Medical)
- 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: 1 generation back to K943862 (1995). 1 ancestor in all.
84 later devices descend from it; 2 cite it directly.
0 of 86 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K943862: Sonicaid Model MR-63 Ambulatory Ecg Recorder, Oxford Instruments Medical Systems (1995) Summary page 2.

## Most influential descendants
- K990727: Syneflash & Syneview (1999), 68 descendants of its own
- K032466: Spiderview (2003), 56 descendants of its own
- K042108: Vista Plus (2005), 46 descendants of its own
- K071641: Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model 9539) (2007), 40 descendants of its own
- K071655: Reveal DX Insertable Cardiac Monitor, Reveal Patient Assistant, Model (S) 9528,9538 (2007), 30 descendants of its own

## Indications for use
The Medilog FD4 Holter monitor is intended to be used in the diagnosis of various cardiac disorders by the recording of ECG in an ambulatory mode. These disorders principally include cardiac arrhythmia’s and myocardial ischeamia. The ECG data is used by the physician as an aid in the diagnosis of the patients condition. In some circumstances the patient may be hospitalised as part of the medical evaluation and Holter monitoring may be performed in conjunction with other non-invasive or invasive procedures. In such cases there is no interaction between the FD4 and other equipment.

Source page: https://510kreport.com/device/K970902
Methodology: https://510kreport.com/methodology