← Product Code [KPS](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPS) · K001888

# UNICORN MODEL SYS0630 (K001888)

_Danish Diagnostic Development A/S · KPS · Jun 30, 2000 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPS/K001888

## Device Facts

- **Applicant:** Danish Diagnostic Development A/S
- **Product Code:** [KPS](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPS.md)
- **Decision Date:** Jun 30, 2000
- **Decision:** SESE
- **Submission Type:** Abbreviated
- **Regulation:** 21 CFR 892.1200
- **Device Class:** Class 2
- **Review Panel:** Radiology
- **Attributes:** 3rd-Party Reviewed

## 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/K001888](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPS/K001888)

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