# K143156: Sentinella 102; Sentinella 102 Horus

- Pathway: 510(k) (Traditional)
- Applicant: General Equipment For Medical Imaging (Oncovision-
- Decided: Nov 18, 2014 after 15 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K162052: Sentinella 102, Sentinella 102 Horus (2016), 0 descendants of its own

## 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 sterile 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/K143156
Methodology: https://510kreport.com/methodology