# K990298: Topographic Imaging Marker

- Pathway: 510(k) (Traditional)
- Applicant: I.Z.I. Medical Products Corp.
- Decided: Mar 3, 1999 after 30 days
- Product code: KPR (System, X-Ray, Stationary)
- Device class: 2
- Regulation: 21 CFR 892.1680
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The 1Z1 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 ajlment 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. Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.

Source page: https://510kreport.com/device/K990298
Methodology: https://510kreport.com/methodology