# K032779: Modification to: Nucamma RX

- Pathway: 510(k) (Traditional)
- Applicant: Is2 Research, Inc.
- Decided: Dec 17, 2003 after 100 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 K982045 (1998). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982045: Nucamma RX, Is2 Research, Inc. (1998) Summary page 1.

## Most influential descendants
- K033956: Mobile Single Circular Camera (MSC) & Mobile Digital Cardiac Camera (MDCC) (2004), 0 descendants of its own

## Indications for use
The intended use of the Mobile Rectangular Single Head Camera 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 platformn and includes accessories such as signal analysis and display equipment, patient and equipment supports, radionuclideanatomicalmarkers, component parts and accessories.

Source page: https://510kreport.com/device/K032779
Methodology: https://510kreport.com/methodology