510(k) Report

Devices descending from K190764

6 later devices reach SurgicalAR through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K230249IkshanaImmersivetouch20231—
+1K221870CarnaLife HoloMedapp S.A.20230—
+1K213215VSI HoloMedicineApoqlar GmbH20222—
+2K253486SKIA-Head (Model: SKIA-ST00)Skia, Inc.20260—
+2K251577Laia XRAugmented Reality Software S.L.20260—
+2K240094LumiNE US; LumiAugmedit B.V.20240—