← Product Code [IWB](/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IWB) · K924849

# LEKSELL GAMMA UNIT MODEL 23004,TYPE B. (K924849)

_Elekta Radiosurgery, Inc. · IWB · Nov 20, 1995 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IWB/K924849

## Device Facts

- **Applicant:** Elekta Radiosurgery, Inc.
- **Product Code:** [IWB](/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IWB.md)
- **Decision Date:** Nov 20, 1995
- **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.

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**Source:** [https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IWB/K924849](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IWB/K924849)

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