Skip to content

RADKOR, RF-159

by Radkor, Inc.

510(k) K883885

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK883885 Date19 Oct 1988ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
KXJ
Device Class
Class II
Regulation
21 CFR Part 892.1980
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 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 RADKOR, RF-159 is a radiologic table used for medical imaging procedures. It is designed to support patients during radiological examinations, providing a stable platform for imaging equipment.

The device is supplied by Radkor, Inc. and has FDA 510K clearance with the product code KXJ. It is a Class II medical device regulated under 892.1980, intended for use in radiology settings.

Other devices from Radkor, Inc.

  • Radkor Sfr-70

    Class I
  • Radkor, Cst-18

    Class I
  • Radkor, Xg-515

    Class I
  • Radkor Xg-325

    Class I
  • Radkor Sfc-21

    Class I
  • Radkor Kob-84

    Class II

See all devices from Radkor, Inc. →

Questions

AI-generated answers, 23 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 RADKOR RF-159 used for?

    The RADKOR RF-159 is a radiologic table designed to support patients during radiological examinations, providing a stable platform for imaging equipment in radiology settings.

  • How is the RADKOR RF-159 supplied?

    The device is supplied by Radkor, Inc. and has FDA 510K clearance with the product code KXJ. It is a Class II medical device regulated under 892.1980.

  • What is the regulatory status of the RADKOR RF-159?

    The RADKOR RF-159 has FDA 510K clearance with the product code KXJ. It is a Class II medical device regulated under 892.1980 and was determined to be substantially equivalent.

  • Is the RADKOR RF-159 reusable or single-use?

    The device data does not specify whether the RADKOR RF-159 is designed for single-use or multiple uses. For specific usage instructions, please consult the manufacturer's documentation.