# K100838: Ergo Imaging System

- Pathway: 510(k) (Special)
- Applicant: Digirad Corp.
- Decided: Apr 23, 2010 after 30 days
- Product code: IYX (Camera, Scintillation (Gamma))
- Device class: 1
- Regulation: 21 CFR 892.1100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K885054 (1989). 15 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961104: Notebook Imager, Digirad Corp. (1997) Summary page 2.
- K982855: Digirad 2020TC Spect Imaging System, Digirad Corp. (1998) Summary page 1.
- K051549: Cardius-1, Cardius-2, Cardius-3, 2020TC Spect Imaging System, Digirad Corp. (2005) Summary page 1.
- K070542: Cardius 1, 2 and 3 Xpo and 2020TC Spect Imaging Systems, Digirad Corp. (2007) Summary page 1.

## Most influential descendants
- K123408: Ergo Imaging System (2013), 0 descendants of its own
- K110384: Dilon 6800 Acella (Acella) (2011), 0 descendants of its own

## Indications for use
The ergo Imaging System is intended to image the distribution of radionuclides in the body by means of a photon radiation detector. In so doing, the system produces images depicting the anatomical distribution of radicisotopes within the human body for interpretation by authorized medical personnel.

Source page: https://510kreport.com/device/K100838
Methodology: https://510kreport.com/methodology