510(k) Report

Devices descending from K061848

9 later devices reach Hyperspectral Tissue Oxygenation Measurement System, Model Oxy VU1 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K113507Kent CameraKent Imaging, Inc.20123—
+1K073656Oxyvu -1 Hyperspectral Tissue Oxygenation (Hto) Measurement SystemHypermed, Inc.20088—
+2K171245Presygen/si-1Christie Medical Holdings, Inc.20180—
+2K163070Kent CameraKent Imaging, Inc.20171—
+2K153426Ox-Imager CSModulated Imaging, Inc.20162—
+2K161237HyperView Hyperspectral Tissue Oxygenation Measurement SystemHypermed Imaging, Inc.20160—
+3K201976SnapshotNIRKent Imaging202001
+3K181623Clarifi Imaging SystemModulated Imaging, Inc.20181—
+4K254129Spectrum-2Neko Health AB20260—