# K021823: Cardiospect D90/Cardio Cam

- Pathway: 510(k) (Traditional)
- Applicant: Nuclear Cardiology Systems, Inc.
- Decided: Jun 17, 2002 after 13 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
Longest line of descent: 1 generation back to K013353 (2002). 1 ancestor in all.
3 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013353: Neurospectquad Gamma Camera, Nuclear Cardiology Systems, Inc. (2002)

## Most influential descendants
- K033874: Myolight (2003), 1 descendant of its own
- K033001: Apex Detector Electronics & Acquisition Interface, Model XL-4 (2003), 1 descendant of its own
- K070589: C! (2007), 0 descendants of its own

## Indications for use
Intended use is to detect & image the distribution of radionuclides in the body when the radiopharmaceutical is administered in the body.

Source page: https://510kreport.com/device/K021823
Methodology: https://510kreport.com/methodology