← Product Code [KPT](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPT) · K010417

# CAL/RAD MARK IV-DOSE CALIBRATOR 34-162 VEENSTRA MODEL # VDC-304 (K010417)

_Nuclear Assoc., Div. Inovision LP · KPT · Apr 26, 2001 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPT/K010417

## Device Facts

- **Applicant:** Nuclear Assoc., Div. Inovision LP
- **Product Code:** [KPT](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPT.md)
- **Decision Date:** Apr 26, 2001
- **Decision:** SESE
- **Submission Type:** Traditional
- **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/K010417](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPT/K010417)

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