Skip to content

Ceiling Mounted Lateral Positioner, Model No. 6896.002

by Continental X-Ray Corp.

510(k) K972442

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK972442 Date11 Sep 1997ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
JAA
Device Class
Class II
Regulation
21 CFR Part 892.1650
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Ceiling Mounted Lateral Positioner, Model No. 6896.002, is a mechanical support device classified as an image-intensified fluoroscopic X-ray system. It is designed to provide stable positioning for imaging equipment during clinical procedures, such as heart catheterization and electrophysiology.

This device is intended for use in clinical settings by trained staff to facilitate cardiac imaging. It is regulated under FDA 510(k) clearance, identified by submission number K972442.

Other devices from Continental X-Ray Corp.

See all devices from Continental X-Ray Corp. →

Questions

AI-generated answers, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary purpose of the Model 6896.002 positioner?

    This device is a mechanical support system designed to provide stable positioning for imaging equipment. It is specifically intended for use during clinical procedures that require cardiac imaging, such as heart catheterization and electrophysiology.

  • Who is authorized to operate this ceiling-mounted device?

    The device is intended for use in clinical settings exclusively by trained staff. This requirement ensures that the equipment is operated safely and effectively to facilitate necessary cardiac imaging procedures.

  • What is the regulatory status of this positioning device?

    The Ceiling Mounted Lateral Positioner, Model 6896.002, is regulated under FDA 510(k) clearance. It is identified by submission number K972442, which confirms its status as a device that has been reviewed and cleared for clinical use.