# K162052: Sentinella 102, Sentinella 102 Horus

- Pathway: 510(k) (Special)
- Applicant: General Equipment For Medical Imaging (Oncovision-
- Decided: Aug 18, 2016 after 24 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: 1 generation back to K143156 (2014). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143156: Sentinella 102; Sentinella 102 Horus, General Equipment For Medical Imaging (Oncovision- (2014) Summary page 4.

## Indications for use
Sentinella 102 (models Sentinella 102 and Sentinella 102 Horus) 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 (models Sentinella 102 and Sentinella 102 Horus) may be used intraoperatively if a protective sheath is used. Sentinella 102 (models Sentinella 102 and Sentinella 102 Horus) may be used at the patient’s bedside, or in Emergency Room or Intensive Care Unit.

Source page: https://510kreport.com/device/K162052
Methodology: https://510kreport.com/methodology