# K042108: Vista Plus

- Pathway: 510(k) (Traditional)
- Applicant: Novacor
- Decided: Jan 19, 2005 after 168 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: 4 generations back to K930806 (1994). 26 ancestors in all.
46 later devices descend from it; 4 cite it directly.
0 of 73 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032466: Spiderview, Ela Medical, Inc. (2003) Summary page 1.
- K022540: Cardio ID+(RZ153+), Rozinn Electronics, Inc. (2002) Summary page 1.
- K993617: Digitrakplus Holter Recorder, Braemar Corp. (1999) Summary page 1.
- K002817: Synetec, Ela Medical, Inc. (2001) Summary page 4.
- K010949: 2010 Plus Holter for Windows, Agilent Technologies (2001) Summary page 4.
- K991786: Mars Unity Workstation with Heart Rate Variability (HRV) Option, General Electric Medical Systems Information Techn (1999) Summary page 4.
- K020825: King of Hearts Express + AF Monitor, Card Guard Scientific Survival, Ltd. (2002) Summary page 5.

## Most influential descendants
- 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
- K082475: Reveal XT Insertable Cardiac Monitor, Model 9529, Revel DX Insertable Cardiac Monitor, Model 9528 (2008), 28 descendants of its own
- K103764: Reveal XT Insertable Cardiac Monitor, Model 9529 and Reveal DX Insertable Cardiac Monitor, Model 9528 (2011), 26 descendants of its own
- K132649: Reveal Linq Insertable Cardiac Monitor (2014), 23 descendants of its own

## Indications for use
Recorder: Vista Plus is intended to record one, two or three channels surface ECG data from ambulatory patients (Holter) for period up to 11 days on one channel, 6 days on two channels, 4 days on three channels. Recorded-data are intended to be analysed by holterSoft Ultima analysis on the ECG data. Software: HolterSoft Ultima is intended to read data acquired by the Vista Plus, analyze, edit, review, report and store these data. The system is intended to be used by trained operators under the direct supervision of a licensed Health Care practitioner in a hospital or a clinic environment.

Source page: https://510kreport.com/device/K042108
Methodology: https://510kreport.com/methodology