← Product Code [IYX](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYX) · K110601

# SENTINELLA 102 (K110601)

_General Equipment For Medical Imaging, S.A. · IYX · Mar 18, 2011 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYX/K110601

## Device Facts

- **Applicant:** General Equipment For Medical Imaging, S.A.
- **Product Code:** [IYX](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYX.md)
- **Decision Date:** Mar 18, 2011
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 892.1100
- **Device Class:** Class 1
- **Review Panel:** Radiology
- **Attributes:** 3rd-Party Reviewed

## Regulatory Identification

A scintillation (gamma) camera is a device intended to image the distribution of radionuclides in the body by means of a photon radiation detector. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.

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**Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYX/K110601](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYX/K110601)

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