← Product Code [KPS](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPS) · K010137

# ORBITER II CCI/SPECT                                   ORBITER II CCI/SPECT (K010137)

_Siemens Medical Solutions USA, Inc. · KPS · Feb 13, 2001 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPS/K010137

## Device Facts

- **Applicant:** Siemens Medical Solutions USA, Inc.
- **Product Code:** [KPS](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPS.md)
- **Decision Date:** Feb 13, 2001
- **Decision:** SESE
- **Submission Type:** Special
- **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/K010137](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPS/K010137)

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