510(k) Report

Devices descending from K042657

9 later devices reach Vioptix Odissey Tissue Oximeter Tissue Oximeter, Model Oxy-2 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K232385OxiplexTS200Iss Medical, Inc.20240—
+1K190334MIMOSA ImagerMimosa Diagnostics, Inc.20190—
+1K133983Intra. OX Handheld Tissue OximeterVioptix, Inc.20145—
+1K141234Odissey Tissue OximeterVioptix, Inc.20140—
+2K163472Intra.Ox Handheld Tissue OximeterVioptix, Inc.20174—
+3K191676Intra.Ox 2.0 Handheld Tissue OximeterVioptix, Inc.20193—
+4K221010Intra.Ox 2.0 Handheld Tissue OximeterVioptix, Inc.20222—
+5K233488Intra.Ox™ 2.0 Handheld Tissue OximeterVioptix, Inc.20241—
+6K250519Lap.Ox™ Laparoscopic Tissue OximeterVioptix, Inc.20250—