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Sirius MRI Markers Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge Needles

by Isoray Medical, Inc.

510(k) K202267

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 5 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 5 Oct 2026. What this means

Regulatory status

as of registry sync 5 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK202267 Date31 Dec 2020ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 5 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  • Withdrawn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
KXK
Device Class
Class II
Regulation
21 CFR Part 892.5730
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 brachytherapy radionuclide source designed for the delivery of radioactive Cs-131 implants. It consists of preloaded strands equipped with MRI-compatible markers for precise localization during and after implantation, ensuring accurate radiation therapy targeting in oncology procedures.

The Sirius MRI Markers Cs-131 Preloaded Strands are supplied sterile and intended for single-use in radiology settings. Each strand is housed in an 18 gauge needle, facilitating implantation into malignant prostatic tissue. The markers enhance MRI visibility, aiding in post-procedure verification, and comply with FDA 510(k) clearance under regulation number 892.5730, classified as a Class II device.

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