510(k) Report

Devices descending from K063494

7 later devices reach Doro Radiolucent Headrest System ( Also Mri-Compatible) and Components through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191740DORO LUCENT® iXI and iMRI Headrest SystemPro Med Instruments GmbH20201—
+1K113748Imris MR/X-Ray Head Fixation Device (HFD)Imris, Inc.201201
+1K103493Head Fiation Device (HFD 100)Imris, Inc.201123
+1K072208Mayfield Disposable and Reusable Titanium Skull PinsIntegra LifeSciences Corporation20074—
+2K250423mb-FIX Cranial Stabilization SystemsMedical Bees GmbH20250—
+2K240319DORO LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp Pediatric Set (1101.040)Pro Med Instruments GmbH20240—
+2K141950HFD100 Rocker Arm AccessoryImris, Inc.20140—