# K110693: Paceart Optima System Software

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic, Inc.
- Decided: Jun 8, 2011 after 89 days
- Product code: KRE (Analyzer, Pacemaker Generator Function, Indirect)
- Device class: 2
- Regulation: 21 CFR 870.3640
- 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 K952065 (1996). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K024278: Paceart System, Medtronic Vascular (2003) Summary page 1.

## Most influential descendants
- K142349: TM eCloud ECG Analysis System (2015), 0 descendants of its own

## Indications for use
The Paceart System is intended for use as a 12-lead electrocardiograph, pacemaker artifact analyzer, and transtelephonic ECG receiving station. It also acts as a database for cardiac patients with or without pacemakers or Implantable Cardioverter Defibrillators.

Source page: https://510kreport.com/device/K110693
Methodology: https://510kreport.com/methodology