← Product Code [KPT](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPT) · K905796

# DOSE CALIBRATOR (K905796)

_Capintec Instruments, Inc. · KPT · Mar 18, 1991 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPT/K905796

## Device Facts

- **Applicant:** Capintec Instruments, Inc.
- **Product Code:** [KPT](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPT.md)
- **Decision Date:** Mar 18, 1991
- **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.

---

**Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPT/K905796](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPT/K905796)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com
