← Product Code [KXJ](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KXJ) · K871827

# OMEGA III ANGIOGRAPHIC TABLE, ROTATION & STEPPER (K871827)

_General Electric Co. · KXJ · Jun 19, 1987 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KXJ/K871827

## Device Facts

- **Applicant:** General Electric Co.
- **Product Code:** [KXJ](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KXJ.md)
- **Decision Date:** Jun 19, 1987
- **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/KXJ/K871827](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KXJ/K871827)

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