← Product Code [KPT](/productcode/KPT) · K813065

# B.D.A.S. (K813065)

_General Electric Co. · KPT · Dec 8, 1981 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K813065

## Device Facts

- **Applicant:** General Electric Co.
- **Product Code:** [KPT](/productcode/KPT.md)
- **Decision Date:** Dec 8, 1981
- **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/device/K813065](https://fda.innolitics.com/device/K813065)

**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
