# K081829: Capimage

- Pathway: 510(k) (Traditional)
- Applicant: Danish Diagnostic Development A/S
- Decided: Jul 11, 2008 after 14 days
- Product code: IYX (Camera, Scintillation (Gamma))
- Device class: 1
- Regulation: 21 CFR 892.1100
- 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 K011611 (2001). 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)
- K011611: Cardiocam Model 9CSY0799, Danish Diagnostic Development A/S (2001) Summary page 1.

## Indications for use
The CapIMAGE Gamma Camera System is intended to produce planar images depicting the anatomical distributions of single photon emitting radioisotopes in the human body within the energy range of 59kev to 167kev. The system provides software applications for processing, analyzing, and displaying medical images for interpretation by medical personnel.

Source page: https://510kreport.com/device/K081829
Methodology: https://510kreport.com/methodology