# K092471: Model Sentinella 102

- Pathway: 510(k) (Traditional)
- Applicant: General Equipment For Medical Imaging, S.A.
- Decided: Oct 2, 2009 after 52 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: 4 generations back to K885054 (1989). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993813: Lumagem Scintillation Camera, Gamma Medica (2000) Summary page 1.
- K022342: EZ-Scope an, EZ-Scope Light, Anzai Medical Co., Ltd. (2002) Summary page 1.

## Indications for use
Sentinella 102 is a mobile gamma camera system which is intended for imaging the distribution of radionuclides in the human body by means of photon detection. The images are intended to be interpreted by qualified personnel. Sentinella 102 may be used intraoperatively if a protective sheath is used. Sentinella 102 may be used at the patient's bedside, or in Emergency Room or Intensive Care Unit.

Source page: https://510kreport.com/device/K092471
Methodology: https://510kreport.com/methodology