# K990494: Modification of Noga

- Pathway: 510(k) (Special)
- Applicant: Biosense, Inc.
- Decided: Sep 3, 1999 after 198 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: 1 generation back to K960542 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960542: NOGA, Biosense, Ltd. (1996) Summary page 1.

## Indications for use
The intended use of the NOGA system is catheter-based cardiac mapping. The NOGA system allows real-time display of cardiac maps in a number of different formats. Maps may be displayed as cardiac electrical activation maps, cardiac electrical propagation maps, cardiac electrical potential maps, cardiac chamber geometry maps, cardiac dynamic maps, cardiac hemodynamic maps, and cardiac electromechanical maps. The acquired patient signals, including body surface ECG, intracardiac electrograms and intracavity or intravascular blood pressure may also be displayed in real time on the display screen.

Source page: https://510kreport.com/device/K990494
Methodology: https://510kreport.com/methodology