← Product Code [KPT](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPT) · K002833

# MODIFICATION TO STANDARD IMAGING PT 1000 ION CHAMBER (K002833)

_Standard Imaging, Inc. · KPT · Sep 28, 2000 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPT/K002833

## Device Facts

- **Applicant:** Standard Imaging, Inc.
- **Product Code:** [KPT](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPT.md)
- **Decision Date:** Sep 28, 2000
- **Decision:** SESE
- **Submission Type:** Special
- **Regulation:** 21 CFR 892.1360
- **Device Class:** Class 2
- **Review Panel:** Radiology

## Regulatory Identification

A radionuclide dose calibrator is a radiation detection device intended to assay radionuclides before their administration to patients.

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**Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPT/K002833](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPT/K002833)

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