510(k) Report

Devices descending from K070426

5 later devices reach Silhouette, Model 1000.01 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K131596Wound Measuring & Monitoring DeviceWoundvision, LLC20134—
+2K251678Swift Ray 1Swift Medical, Inc.20260—
+2K251255LymphaTech Mobile 3D Measuring ToolLymphatech, Inc.20250—
+2K230734Multispectral Imager Kit (MSI Kit) (300-00015), Multispectral Imager (MSI) (300-00009)Precision Healing, LLC20230—
+2K190074Presero 3D Scanning SystemCertis Health20190—