510(k) Report

Devices descending from K101707

3 later devices reach Fulaccess Model 1.0 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K182855ProKnow DSProknow, LLC20192—
+2K251363ProKnow DSElekta Solutions AB20250—
+2K193498Infinitt RT PACSInfinitt Healthcare Co., Ltd.20200—