← Product Code [IWJ](/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IWJ) · K850571

# I-125 IMPLANT GUN (K850571)

_Mick Radio-Nuclear Instruments, Inc. · IWJ · Mar 26, 1985 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IWJ/K850571

## Device Facts

- **Applicant:** Mick Radio-Nuclear Instruments, Inc.
- **Product Code:** [IWJ](/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IWJ.md)
- **Decision Date:** Mar 26, 1985
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 892.5650
- **Device Class:** Class 1
- **Review Panel:** Radiology

## Regulatory Identification

A manual radionuclide applicator system is a manually operated device intended to apply a radionuclide source into the body or to the surface of the body for radiation therapy. This generic type of device may include patient and equipment supports, component parts, treatment planning computer programs, and accessories.

---

**Source:** [https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IWJ/K850571](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IWJ/K850571)

**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