← Product Code [KPS](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPS) · K001026

# 3D-MSPECT (K001026)

_The Reagents of the University of Michigan · KPS · Jun 20, 2000 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPS/K001026

## Device Facts

- **Applicant:** The Reagents of the University of Michigan
- **Product Code:** [KPS](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPS.md)
- **Decision Date:** Jun 20, 2000
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 892.1200
- **Device Class:** Class 2
- **Review Panel:** Radiology

## Regulatory Identification

An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. 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/KPS/K001026](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPS/K001026)

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