# K040057: Mobile Compact Digital Cardiac Camera

- Pathway: 510(k) (Special)
- Applicant: Is2 Research, Inc.
- Decided: Feb 2, 2004 after 20 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 K033199 (2003). 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)
- K033199: Compact Digital Cardiac Camera (CDCC), Is2 Medical Systems, Inc. (2003) Summary page 1.

## Indications for use
The intended use of the Mobile Compact Digital Cardiac (MCDCC) is to detect the location and distribution of gamma ray emitting radionuclides in the body and store data for analysis. This device resides on a mobile platform and includes accessories such as signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts and accessories.

Source page: https://510kreport.com/device/K040057
Methodology: https://510kreport.com/methodology