# K033956: Mobile Single Circular Camera (MSC) & Mobile Digital Cardiac Camera (MDCC)

- Pathway: 510(k) (Special)
- Applicant: Is2 Research, Inc.
- Decided: Jan 20, 2004 after 29 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: 2 generations back to K982045 (1998). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032779: Modification to: Nucamma RX, Is2 Research, Inc. (2003) Summary page 1.

## Indications for use
The intended use of the Mobile Single Circular (MSC) and the Mobile Digital Cardiac Camera (MDCC) 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/K033956
Methodology: https://510kreport.com/methodology