Radiomed Marker

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

510(k) Number

K022326 ↗

FDA Product Code

JAK

Device Class

Class II

Regulation

21 CFR Part 892.1750

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Pre-Loaded Visicoil

  Class II

  FDA 510(k) K070305 Active Cleared 7 Mar 2007

• Radiomed Soft Tissue Marker

  Class II

  FDA 510(k) K031206 Active Cleared 21 May 2003

• Genetra

  Class II

  FDA 510(k) K013660 Active Cleared 5 Dec 2001

• Pre-Loaded Gold Visicoil Ck Marker

  Class II

  FDA 510(k) K120859 Active Cleared 19 Apr 2012

• Radiomed Source

  Class II

  FDA 510(k) K001070 Active Cleared 24 Oct 2000

• Visicoil MR Marker (User Loaded), Visicoil MR Marker (Pre-Loaded)

  Class II

  FDA 510(k) K161724 Active Cleared 28 Apr 2017

• What is the Radiomed Marker used for?

  The Radiomed Marker is used to radiographically mark soft tissue for future therapeutic procedures. It serves as a radiographic reference point visible under fluoroscopy, ultrasound, CT, and x-ray imaging, allowing clinicians to locate the marked tissue during subsequent interventions.

• Is the Radiomed Marker sterile and how is it supplied?

  The Radiomed Marker is non-sterile and supplied as a single-use device. It is intended for one-time implantation and should not be reused, as re-use could compromise patient safety and device integrity.

• What are the physical specifications of the Radiomed Marker?

  The Radiomed Marker is a rhodium coil with a diameter of 0.35mm. It is designed to be implantable in soft tissue and provides visibility under multiple imaging modalities including fluoroscopy, ultrasound, CT, and x-ray.

• What regulatory pathway was used for the Radiomed Marker?

  The Radiomed Marker received FDA 510(k) clearance under K-number K022326, indicating it was found substantially equivalent to a legally marketed predicate device through the traditional 510(k) review process.