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Remote Hand Control To The Inflatable Positioning Cushion (A.K.A. Imageair)

by Kci New Technologies, Inc.

510(k) K980235

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 NumberK980235 Date9 Apr 1998ClearedStatusActive

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  • Withdrawn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
IZH
Device Class
Class II
Regulation
21 CFR Part 892.1710
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 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 Remote Hand Control To The Inflatable Positioning Cushion (A.K.A. Imageair) is a device used for controlling an inflatable positioning cushion. It is classified as a System, X-Ray, Mammographic device.

The device is supplied with a remote hand control and is intended for use on nuclear imaging tables for Scintimammography procedures, allowing for comfortable and anatomically correct prone positioning of the patient. It has been assigned the product code IZH and is classified as a Class II device with special controls.

Other devices from Kci New Technologies, Inc.

Questions

AI-generated answers, 24 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 Imageair Remote Hand Control used for?

    The Imageair Remote Hand Control is used for controlling an inflatable positioning cushion on nuclear imaging tables for Scintimammography procedures, allowing for comfortable and anatomically correct prone positioning of the patient.

  • Is the Imageair Remote Hand Control supplied with any additional components?

    The device is supplied with a remote hand control.

  • What type of device is the Imageair Remote Hand Control classified as?

    The Imageair Remote Hand Control is classified as a System, X-Ray, Mammographic device, and is assigned the product code IZH.

  • What is the regulatory classification of the Imageair Remote Hand Control?

    The Imageair Remote Hand Control is classified as a Class II device with special controls.