TOPOGRAPHIC IMAGING MARKER

• K Number: K990242
• Device Name: TOPOGRAPHIC IMAGING MARKER
• Manufacturer: I.Z.I. MEDICAL PRODUCTS CORP.
• Date Cleared: 1999-03-03 ( 37 days)
• Product Code: KPR
• Regulation Number: 892.1680
• Type: Traditional
• Panel: RA
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

The 121 Topographic Imaging Marker provides a location on the patient's skin to reference internal anatomy and pathology. Given any radiographic information thereby, a physician or technician can pinpoint the location of the patient's ailment on the skin surface in reference to an internal pathologic process. The subsequent radiographic study would enable one to cross reference the skin position indicated by the patient with the internally demonstrated pathologic process shown on the study.

The IZI Topographic Imaging Marker is used for all fluoroscopic procedures, all standard radiographic procedures, localization of internal anatomy and pathology, as well as being able to direct biopsy procedures.

Device Description

Topographic Imaging Marker

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for a device called "Topographic Imaging Marker." This document does not contain any information regarding acceptance criteria, study data, sample sizes, expert qualifications, or ground truth establishment relevant to the device's performance.

The letter primarily confirms that the device has been found substantially equivalent to legally marketed predicate devices and outlines regulatory information for marketing the device. It identifies the device's intended use and target population but does not include any performance data or study details.

Therefore, I cannot answer your request with the input provided.

Regulation Number and Section

§ 892.1680 Stationary x-ray system.

(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.