# K982045: Nucamma RX

- Pathway: 510(k) (Traditional)
- Applicant: Is2 Research, Inc.
- Decided: Sep 2, 1998 after 84 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.
2 later devices descend 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)
- None. The FDA summary names its predicate without a number.
- (no number) ISOCAM I gamma camera: named in the summary without a submission number

## Most influential descendants
- K032779: Modification to: Nucamma RX (2003), 1 descendant of its own
- K033956: Mobile Single Circular Camera (MSC) & Mobile Digital Cardiac Camera (MDCC) (2004), 0 descendants of its own

## Indications for use
To detect or image the distribution of radionuclides in the body or organ, using the following technique(s):

Source page: https://510kreport.com/device/K982045
Methodology: https://510kreport.com/methodology