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Tracer Implantation Kit, Index Implantation Kit

by Navotek Medical, Ltd.

510(k) K110971

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 NumberK110971 Date10 Jan 2012ClearedStatusActive

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  • Withdrawn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
IYE
Device Class
Class II
Regulation
21 CFR Part 892.5050
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 Tracer/Index Implantation Kit designed to provide fiducial markers for soft tissue localization. The kit includes radioactive sources made of platinum/iridium, which are implanted in the prostate to emit photons. These markers are used in conjunction with the Navotek RealEye system to assist in aligning and monitoring patient positioning relative to the isocenter of a linear accelerator during radiotherapy.

The Tracer Implantation Kit is intended for single-use in a radiology setting. It is supplied sterile and classified under product code IYE as a Class II medical device under FDA regulations (892.5050). The kit received FDA 510(k) clearance (K110971) as substantially equivalent, with review by the Radiology Advisory Committee (RA). No third-party review was required, and the device is not intended for MRI use.

Other devices from Navotek Medical, Ltd.

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 Tracer/Index Implantation Kit used for?

    The kit is designed to implant radioactive platinum/iridium fiducial markers into the prostate. These markers emit photons, which help align and monitor patient positioning relative to the isocenter of a linear accelerator during radiotherapy. This ensures precise targeting and reduces errors in treatment delivery.

  • How is the kit supplied and where is it intended for use?

    The kit is supplied sterile and intended for single-use in a radiology setting. It is not reusable and must be used in controlled environments where radioactive materials are handled, such as dedicated radiology or interventional suites.

  • Are the radioactive sources safe for MRI use?

    No, the kit is explicitly not intended for MRI use. The platinum/iridium markers contain radioactive elements that could interfere with MRI imaging or pose safety risks during the procedure.

  • What regulatory approval does this kit have?

    The kit received FDA 510(k) clearance (K110971) as substantially equivalent to a predicate device, with review by the Radiology Advisory Committee (RA). It is classified as a Class II medical device under product code IYE.

  • How do the markers improve radiotherapy accuracy?

    The implanted markers emit detectable photons, which the Navotek RealEye system uses to track the prostate’s position in real time. This continuous feedback ensures the treatment beam remains aligned with the target area, reducing the risk of missing the tumor or damaging healthy tissue.