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Darpac 2000 Superficial X-Ray Therapy System

by Gulmay Medical, Ltd.

510(k) K962613

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

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 NumberK962613 Date27 Sep 1996ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-0389-2022 FDA Class II initiated 27 Aug 2021

    Base plate may detach from the main body of the treatment applicator.

    • Terminated Z-0174-2022 FDA Class II initiated 26 Apr 2021

    If a saved treatment plan with 2 opposing beams is edited prior to approval, then Beam 2 is not updated with the changed parameters upon selecting save, resulting in error messages during the treatment and possible mis-treatment.

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  • Withdrawn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
JAD
FDA applicant
Gulmay Medical , Ltd.
Device Class
Class II
Regulation
21 CFR Part 892.5900
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 Darpac 2000 Superficial X-Ray Therapy System is a therapeutic X-ray system designed for medical use within the field of radiology. It functions as a device for delivering superficial X-ray therapy to patients.

This system is classified as a Class II medical device under regulation number 892.5900. It received FDA 510(k) clearance on September 27, 1996, under the product code JAD.