← Product Code [IXR](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXR) · K950981

# ULTRA-PRO ULTRASOUND SCANNING TABLE MODEL #056-650 (K950981)

_Biodex Medical Systems, Inc. · IXR · Apr 3, 1995 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXR/K950981

## Device Facts

- **Applicant:** Biodex Medical Systems, Inc.
- **Product Code:** [IXR](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXR.md)
- **Decision Date:** Apr 3, 1995
- **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.

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**Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXR/K950981](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXR/K950981)

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