# K042002: Synescope, Easyscope, Synecom, Holterreader

- Pathway: 510(k) (Traditional)
- Applicant: Ela Medical, Inc.
- Decided: Oct 20, 2004 after 86 days
- Product code: DQK (Computer, Diagnostic, Programmable)
- Device class: 2
- Regulation: 21 CFR 870.1425
- 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 K930806 (1994). 21 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002817: Synetec, Ela Medical, Inc. (2001) Summary page 1.
- K990727: Syneflash & Syneview, Ela Medical, Inc. (1999) Summary page 1.
- K004017: H-Scribe, Mortara Instrument, Inc. (2001) Summary page 1.
- K930564: Holter for Windows, North East Monitoring, Inc. (1995) Summary page 2.
- K020213: Netlink/Netscan, Rozinn Electronics, Inc. (2002) Summary page 2.
- K896396: Mida System, Models 1000/1100, Medical Graphics Corp. (1990) Summary page 2.

## Most influential descendants
- K193177: CER-S (2020), 2 descendants of its own
- K213861: CER-S (2022), 1 descendant of its own
- K243312: CER-S (2025), 0 descendants of its own

## Indications for use
SyneScope is intended to analyze, edit, review, report, store and transfer multi-channel ECG recording on pediatric or adult patients (for periods up to 96 hours). These recordings are provided by: - SpiderView Holter ECG recorder (K032466), - SyneFlash Holter ECG (K990727), or - other compatible cassette tape recorder. In addition, any ISHNE compatible recording can be read by SyneScope. EasyScope is intended to analyze, edit, review, report, store and transfer 2-3 channel ECG recording on pediatric or adult patients (for periods up to 96 hours). These recordings are provided by: - SpiderView Holter ECG recorder (K032466), - SyneFlash Holter ECG (K990727), or - other compatible cassette tape recorder. SyneCom is intended to download, transfer for analysis, print and store multi-channel ECG recording on pediatric or adult patients (for periods up to 96 hours). These recordings are provided by: - SpiderView Holter ECG recorder (K032466), - SyneFlash Holter ECG (K990727) HolterReader is intended to view and print Holter reports from SyneScope, EasyScope and SyneCom. SyneScope, EasyScope, SyneCom and HolterReader are intended to be used under the supervision of licensed and trained practitioners, in a hospital or clinic setting. Applications for Holter monitoring include, but are not limited to, evaluation of the following: * Patient symptoms such as syncope, dizziness or palpitations. * Ischemia, especially in patients who cannot exercise or in patients with variant angina. * Function of an implanted pacemaker or defibrillator.

Source page: https://510kreport.com/device/K042002
Methodology: https://510kreport.com/methodology