510(k) Report

Devices descending from K112770

9 later devices reach Nvision Vle Imaging System, Nvision Vle Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K162466LuminScan (TM) Imaging SystemMicro-Tech (Nanjing) Co., Ltd.20160—
+1K120800Nvision Vle Imaging SystemNinepoint Medical, Inc.20136—
+1K121195Nvision Vle Imaging System Nvision Vle CatheterNinepoint Medical, Inc.20120—
+2K143678NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation AccessoryNinepoint Medical, Inc.201551
+3K182261NvisionVLE Imaging System, NvisionVLE Optical ProbeNinepoint Medical, Inc.20181—
+3K153479NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking…Ninepoint Medical, Inc.20162—
+4K191117NvisionVLE Low-profile Optical ProbeNinepoint Medical, Inc.20190—
+4K182616NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation SystemNinepoint Medical, Inc.20181—
+5K251730LIA Console (542-7)Leadoptik, Inc.20250—