# K033199: Compact Digital Cardiac Camera (CDCC)

- Pathway: 510(k) (Traditional)
- Applicant: Is2 Medical Systems, Inc.
- Decided: Nov 12, 2003 after 41 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K003882: Nucamma BI90, Is2 Research, Inc. (2001). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K040057: Mobile Compact Digital Cardiac Camera (2004), 0 descendants of its own

## Indications for use
The intended use of the COMPACT DIGITAL CARDIAC CAMERA is to detect the location and distribution of gamma ray emitting radionuclides in the body and store data for analysis. This device includes accessories such as signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts and accessories. To detect or image the distribution of radionuclides in the body or organ using the following technique(s): Planar Imaging; Tomographic Imaging (SPECT) for non-Positron emitter.

Source page: https://510kreport.com/device/K033199
Methodology: https://510kreport.com/methodology