← Product Code [IXR](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXR) · K000412

# VISION R/F TILTING TABLE (K000412)

_Villa Sistemi Medicali S.P.A. · IXR · Apr 24, 2000 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXR/K000412

## Device Facts

- **Applicant:** Villa Sistemi Medicali S.P.A.
- **Product Code:** [IXR](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXR.md)
- **Decision Date:** Apr 24, 2000
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 892.1980
- **Device Class:** Class 2
- **Review Panel:** Radiology

## Regulatory Identification

A radiologic table is a device intended for medical purposes to support a patient during radiologic procedures. The table may be fixed or tilting and may be electrically powered.

## Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.

---

**Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXR/K000412](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXR/K000412)

**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