← Product Code [IXI](/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IXI) · K953894

# SIEMENS MULTILEAF COLLIMATOR (K953894)

_Siemens Medical Solutions USA, Inc. · IXI · Nov 13, 1995 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IXI/K953894

## Device Facts

- **Applicant:** Siemens Medical Solutions USA, Inc.
- **Product Code:** [IXI](/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IXI.md)
- **Decision Date:** Nov 13, 1995
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 892.5710
- **Device Class:** Class 2
- **Review Panel:** Radiology

## Regulatory Identification

A radiation therapy beam-shaping block is a device made of a highly attenuating material (such as lead) intended for medical purposes to modify the shape of a beam from a radiation therapy source.

---

**Source:** [https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IXI/K953894](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IXI/K953894)

**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