← Back to catalogue

Topographic Imaging Marker

FDA 510(k)

Class II (US FDA 510(k))

510(k) K990298

by I.Z.I. Medical Products Corp.

Identifiers

510(k) Number
K990298 FDA 510(k)
FDA Product Code
KPR FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.1680 FDA 510(k)
Regulation Number
892.1680 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Topographic Imaging Marker is a radiopaque skin marker classified as a Radiopaque Skin Marker (FDA classification KPR). It is designed to provide a visible reference point on fluoroscopic or radiographic images, enabling correlation between external skin landmarks and internal anatomical structures or pathologies during imaging procedures.

This device is applied directly to the patient’s skin prior to imaging and is intended for single-use. It is regulated under FDA 510(k) clearance (K990298) and falls under the Radiology specialty. The marker is non-sterile and must be stored in a clean, dry environment until use. No MRI safety information is specified in the available data.

Frequently asked questions

What is the primary purpose of the Topographic Imaging Marker and how does it function during imaging procedures?

The Topographic Imaging Marker is designed to serve as a radiopaque reference point on fluoroscopic or radiographic images. It helps correlate external skin landmarks with internal anatomical structures or pathologies, ensuring accurate spatial orientation during imaging. By applying it directly to the patient’s skin before imaging, clinicians can visually identify key areas on both external and internal scans, improving precision in procedures like biopsies or interventions.

Is the Topographic Imaging Marker intended for reuse, or is it meant to be used only once?

The Topographic Imaging Marker is explicitly intended for single-use only. This design ensures patient safety and sterility, as reuse could introduce contamination or compromise the marker’s integrity. Always dispose of it after a single procedure.

How should the Topographic Imaging Marker be stored before use, and is it sterile?

The marker is non-sterile, so it must be stored in a clean, dry environment to prevent contamination. Avoid exposure to moisture, extreme temperatures, or direct sunlight. Proper storage ensures its radiopacity and usability when needed for imaging procedures.

What regulatory pathway was followed for FDA clearance of this device, and what does that mean for its use?

The Topographic Imaging Marker received FDA clearance through a 510(k) submission (K990298), classified under the Radiology specialty with a product code of KPR (Radiopaque Skin Marker). This means the manufacturer demonstrated it is *substantially equivalent* to a legally marketed device already on the market, ensuring it meets safety and effectiveness standards for its intended use as a radiopaque skin marker.

Can this marker be used in MRI procedures, or is it only compatible with fluoroscopy or X-ray imaging?

The available data does not specify MRI safety information for the Topographic Imaging Marker, meaning its compatibility with MRI environments is not confirmed. It is explicitly designed for fluoroscopic or radiographic imaging only, so caution should be exercised if considering MRI use.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: TOPOGRAPHIC IMAGING MARKER (K990242) — FDA 510(k) | Innolitics, TOPOGRAPHIC IMAGING MARKER by I.Z.I. MEDICAL PRODUCTS CORP. | FDA 510 ..., TOPOGRAPHIC IMAGING MARKER 510 (k) K990242 - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
I.Z.I. Medical Products Corp.

Sources (1)

  • FDA 510(k) K990298 24 fields · synced Sep 19, 2026