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Movable Add-on Couch for Outlook

by Philips Medical Systems (Cleveland), Inc.

510(k) K960973

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

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK960973 Date29 May 1996ClearedStatusActive

Official records

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  • Withdrawn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
LNH
Device class
Class II
Regulation
21 CFR Part 892.1000
Advisory committee
Radiology
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

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

The Movable Add-on Couch for Outlook is a device designed to enable transfer of the patient together with the upper couch plate to and from a movable base directly into the Outlook patient handling system. It is classified as a System, Nuclear Magnetic Resonance Imaging under FDA device classification.

The device received FDA 510(k) clearance (K960973) on May 29, 1996, following a traditional review process. It is manufactured by Philips Medical Systems (Cleveland), Inc. and is intended for use in radiology settings.

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