← Product Code [IYX](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYX) · K935273

# VISION FX 40 & 80 SERIES GAMMA CAMERA (K935273)

_Summit Nuclear · IYX · Apr 18, 1994 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYX/K935273

## Device Facts

- **Applicant:** Summit Nuclear
- **Product Code:** [IYX](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYX.md)
- **Decision Date:** Apr 18, 1994
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 892.1100
- **Device Class:** Class 1
- **Review Panel:** Radiology

## 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/K935273](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYX/K935273)

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