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Refurbish Diagnostic X-Ray Equipment

by Chemarts and Assoc., Inc.

510(k) K863309

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 NumberK863309 Date16 Jan 1987ClearedStatusActive

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  • Withdrawn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
KPR
Device Class
Class II
Regulation
21 CFR Part 892.1680
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.

Refurbish Diagnostic X-Ray Equipment is a Class II X-ray system manufactured by Chemarts and Assoc., Inc. It is a stationary diagnostic system intended to generate and control x-rays for examination of various anatomical regions.

The device is used in radiology settings and is supplied as refurbished equipment. It received FDA 510(k) clearance with K-number K863309 on January 16, 1987, and is classified under product code KPR. The device is not specified as single-use or reusable, and no information regarding sterility, MRI safety, or storage conditions is provided.

Questions

AI-generated answers, 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.

  • What is the Refurbish Diagnostic X-Ray Equipment used for?

    The Refurbish Diagnostic X-Ray Equipment is used for examination of various anatomical regions in radiology settings.

  • Is the Refurbish Diagnostic X-Ray Equipment supplied as new or refurbished equipment?

    The Refurbish Diagnostic X-Ray Equipment is supplied as refurbished equipment.

  • What is the regulatory status of the Refurbish Diagnostic X-Ray Equipment?

    The Refurbish Diagnostic X-Ray Equipment received FDA 510(k) clearance with K-number K863309 on January 16, 1987.