Search Results
Found 3 results
510(k) Data Aggregation
(37 days)
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.
Topographic Imaging Marker
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.
Ask a specific question about this device
(30 days)
The IZI 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.
Not Found
This document is a 510(k) clearance letter from the FDA for a medical device called the "Topographic Imaging Marker". It is a regulatory document and does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.
Therefore, I cannot provide the requested information based on the input text. The input text is a regulatory clearance letter, not a device performance study or clinical trial report. It confirms that the device is "substantially equivalent" to legally marketed predicate devices, but it does not detail performance metrics, study designs, sample sizes, or ground truth establishment.
Ask a specific question about this device
(36 days)
Ask a specific question about this device
Page 1 of 1