510(k) Report

Devices descending from K182336

5 later devices reach SubtlePET through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K213140Claritas iPETClaritas Healthtech Pte, Ltd.20212—
+1K211964SubtlePETSubtle Medical, Inc.20212—
+2K261305Micsi-PetMicrostructure Imaging, Inc.20260—
+2K254013SubtleHD-PET (1.x)Subtle Medical, Inc.20260—
+2K244016iPETcertum (v1.0)Claritas Healthtech Pte, Ltd.20250—