510(k) Report

Devices descending from K063391

9 later devices reach Sapheneia Clarity through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K212550Hura CTP v1.0Hura Imaging, Inc.20210—
+1K182336SubtlePETSubtle Medical, Inc.20185—
+1K140139ClearviewhdClearview Diagnostics, Inc.20140—
+1K140395Vitrea Image Denoising SoftwareVital Images, Inc.20140—
+2K213140Claritas iPETClaritas Healthtech Pte, Ltd.20212—
+2K211964SubtlePETSubtle Medical, Inc.20212—
+3K261305Micsi-PetMicrostructure Imaging, Inc.20260—
+3K254013SubtleHD-PET (1.x)Subtle Medical, Inc.20260—
+3K244016iPETcertum (v1.0)Claritas Healthtech Pte, Ltd.20250—