← Product Code [IWB](/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IWB) · K041125

# MASEP SRRS GAMMA RAYS STEREOTACTIC RADIATION THERAPY SYSTEM FOR HEADS (MASEP GAMMA THERAPY SYSTEM) (K041125)

_Masep Med Science & Tech. Development (Shenzhen) C · IWB · Dec 30, 2004 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IWB/K041125

## Device Facts

- **Applicant:** Masep Med Science & Tech. Development (Shenzhen) C
- **Product Code:** [IWB](/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IWB.md)
- **Decision Date:** Dec 30, 2004
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 892.5750
- **Device Class:** Class 2
- **Review Panel:** Radiology

## Regulatory Identification

A radionuclide radiation therapy system is a device intended to permit an operator to administer gamma radiation therapy, with the radiation source located at a distance from the patient's body. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts (including beam-limiting devices), and accessories.

---

**Source:** [https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IWB/K041125](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IWB/K041125)

**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