# K972509: Cequal-Quantitative Analysis for Cardiolite Executing on the Medasys Digital Systems Computer

- Pathway: 510(k) (Traditional)
- Applicant: Nuccardiac Software, Inc.
- Decided: Sep 8, 1997 after 67 days
- Product code: KPS (System, Tomography, Computed, Emission)
- Device class: 2
- Regulation: 21 CFR 892.1200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
To detect or image the distribution of radionuclides in the body or organ, using the following technique(s).

Source page: https://510kreport.com/device/K972509
Methodology: https://510kreport.com/methodology