510(k) Report

Devices descending from K211964

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K261305Micsi-PetMicrostructure Imaging, Inc.20260—
+1K254013SubtleHD-PET (1.x)Subtle Medical, Inc.20260—