510(k) Report

Devices descending from K042894

14 later devices reach Imalux Niris Imaging System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160240Perimeter Otis™ 1.0 Optical Coherence Tomography SystemPerimeter Medical Imaging, Inc.20163—
+1K112770Nvision Vle Imaging System, Nvision Vle CatheterNinepoint Medical, Inc.20119—
+2K171560OTIS Optical Coherence Tomography SystemPerimeter Medical Imaging, Inc.20172—
+2K162466LuminScan (TM) Imaging SystemMicro-Tech (Nanjing) Co., Ltd.20160—
+2K120800Nvision Vle Imaging SystemNinepoint Medical, Inc.20136—
+2K121195Nvision Vle Imaging System Nvision Vle CatheterNinepoint Medical, Inc.20120—
+3K190404OTIS Optical Coherence Tomography SYstemPerimeter Medical Imaging, Inc.20191—
+3K143678NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation AccessoryNinepoint Medical, Inc.201551
+4K203578OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography SystemPerimeter Medical Imaging Ai, Inc.20210—
+4K182261NvisionVLE Imaging System, NvisionVLE Optical ProbeNinepoint Medical, Inc.20181—
+4K153479NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking…Ninepoint Medical, Inc.20162—
+5K191117NvisionVLE Low-profile Optical ProbeNinepoint Medical, Inc.20190—
+5K182616NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation SystemNinepoint Medical, Inc.20181—
+6K251730LIA Console (542-7)Leadoptik, Inc.20250—