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CT HDR Tandem/Ring Applicator with Rectal Retractor

by Mick Radio-Nuclear Instruments, Inc.

510(k) K030110

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

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 NumberK030110 Date3 Apr 2003ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-2081-2008 FDA Unclassified (pre-2012) initiated 12 Mar 2008

    Medical device may exhibit inaccurate positioning and lead to unintended dose delivery during brachytherapy 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  • Withdrawn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
JAQ
Device Class
Class II
Regulation
21 CFR Part 892.5700
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

This device is a remote-controlled radionuclide applicator system designed for high-dose-rate (HDR) brachytherapy. It combines a tandem and ring applicator configuration with a rectal retractor to facilitate precise placement within the treatment cavity, enabling targeted radiation delivery for gynecological or prostate cancer therapies. The system integrates imaging compatibility for CT-guided localization, ensuring accurate dosimetry and stable applicator positioning during therapy.

The applicator is supplied as a reusable medical device, intended for use in radiology settings under sterile conditions. It is classified under FDA product code JAQ as a Class II device with special controls, reflecting its role in remote-controlled radionuclide applications. Storage and handling must adhere to manufacturer guidelines to maintain sterility and functionality. No additional regulatory approvals beyond the FDA 510(k) clearance are referenced in the device data.

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Questions

AI-generated answers, 1 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 CT HDR Tandem/Ring Applicator with Rectal Retractor used for?

    This device is designed for high-dose-rate (HDR) brachytherapy, specifically to deliver targeted radiation therapy for gynecological or prostate cancer. The tandem and ring applicator configuration, combined with a rectal retractor, ensures precise placement within the treatment cavity. CT imaging compatibility allows for accurate localization and stable positioning during therapy, improving dosimetry and treatment outcomes.

  • Is the CT HDR Tandem/Ring Applicator with Rectal Retractor reusable or single-use?

    The device is supplied as a reusable medical device. It is intended for use in radiology settings under sterile conditions, meaning it must be properly cleaned, sterilized, and maintained between uses to ensure safety and functionality. Adherence to manufacturer guidelines for storage and handling is critical to preserve sterility and performance.

  • How does the rectal retractor enhance the functionality of this applicator?

    The rectal retractor included with this applicator helps to maintain clear access and stable positioning within the treatment cavity. By retracting the rectal wall, it reduces interference during applicator placement, ensuring accurate alignment and minimizing displacement during radiation delivery. This contributes to precise dosimetry and effective targeting of the tumor while protecting surrounding tissues.

  • What regulatory pathway does this device follow?

    This device has received FDA clearance through a 510(k) submission, specifically under product code JAQ, which classifies it as a Class II device with special controls. The clearance was granted by the Radiology Advisory Committee (RA) and reflects its use as a remote-controlled radionuclide applicator. No additional regulatory approvals beyond the FDA 510(k) clearance are referenced in the device data.

  • What storage and handling guidelines should be followed to maintain sterility and functionality?

    To maintain sterility and functionality, the device must be stored and handled according to the manufacturer’s guidelines. This includes proper cleaning, sterilization procedures, and storage in a clean, dry environment protected from contamination or physical damage. Regular inspections for wear or damage are also recommended to ensure the device remains safe and effective for repeated use in clinical settings.