# K123408: Ergo Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Digirad Corp.
- Decided: Jan 15, 2013 after 71 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: 6 generations back to K885054 (1989). 25 ancestors in all.
No later device cites it as a predicate yet.
3 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100838: Ergo Imaging System, Digirad Corp. (2010) Summary page 1.
- K111791: Lumagem Molecular Breast Imaging System, Gamma Medica-Ideas Incorporated (2011) Summary page 1.

## 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 radioisotopes within the human body for interpretation by authorized medical personnel. The ergo Imaging System is used by trained medical personnel to perform nuclear medicine studies. It is indicated for lymphatic scintigraphy and parathyroid scintigraphy, It can be used intraoperatively when protected by sterile drapes. It is also indicated to aid in the evaluation of lesions in the breast and other small body parts. When used for breast imaging, it is indicated to serve as an adjunct to mammography or other primary breast imaging modalities.

Source page: https://510kreport.com/device/K123408
Methodology: https://510kreport.com/methodology