Microselectron-Hdr Version 2

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K953946 ↗

FDA Product Code

JAQ

Device Class

Class II

Regulation

21 CFR Part 892.5700

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Microselection Interstitial Remote Afterload Sys

  Class II

  FDA 510(k) K853912 Active Cleared 21 May 1986

• Plato Brachytheraphy Treatment Planning System

  Class II

  FDA 510(k) K915622 Active Cleared 25 Sep 1992

• Microselectron - Hdr for Mobile Environment

  Class II

  FDA 510(k) K925956 Active Cleared 19 Nov 1993

• N 800 Hf

  Class I

  FDA 510(k) K953831 Active Cleared 8 Sep 1995

• Selectron Hdr Remote Afterloader

  Class II

  FDA 510(k) K852842 Active Cleared 10 Jan 1986

• Pulsed Selectron

  Class II

  FDA 510(k) K902533 Active Cleared 12 Oct 1990

See all devices from Nucletron-Oldelft Corp. →

• What is the Microselectron-HDR Version 2 used for?

  The Microselectron-HDR Version 2 is a Class II medical device designed for remote-controlled application of radionuclides for therapeutic purposes in radiology procedures.

• Is the Microselectron-HDR Version 2 a single-use or reusable device?

  The device information does not specify whether the Microselectron-HDR Version 2 is single-use or reusable. This detail would be found in the device's specific instructions for use provided by the manufacturer.

• What regulatory approvals does the Microselectron-HDR Version 2 have?

  The Microselectron-HDR Version 2 received FDA 510(k) clearance with number K953946 on August 13, 1996, after being submitted on August 21, 1995. It is classified as Substantially Equivalent under product code JAQ and regulation number 892.5700.

• What sizes and models of the Microselectron-HDR Version 2 are available?

  The device data does not specify available sizes or models for the Microselectron-HDR Version 2. This information would be detailed in the manufacturer's product catalog or instructions for use.

• How should the Microselectron-HDR Version 2 be stored?

  The device data does not include specific storage instructions. Proper storage requirements would be outlined in the manufacturer's instructions for use, which should be consulted for handling and storage guidelines.