510(k) Report

Devices descending from K082060

16 later devices reach Cranial Image Guided Surgery System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K201752Disposable Pre-calibrated SuctionBrainlab AG20210—
+1K190250Microscope NavigationBrainlab AG20190—
+1K172820Microscope Navigation SoftwareBrainlab AG20181—
+1K100038Disposable Reflective Marker SpheresBrainlab AG201023
+1K092467Vectorvision Cranial, Vectorvision Ent, Kolibri Cranial, Kolibri Ent, Cranial Essential…Brainlab AG201010Class I
+2K231897NeuroAlign softwareMedivis, Inc.20250—
+2K192703Cranial Image Guided Surgery System, Navigation Software Cranial, Navigation Software…Brainlab AG20203—
+2K171661Scopis Extended Instrument Set EMScopis GmbH20173—
+2K111443X12 Sterile Reflective Marker SpherePinsco Inc. Dba B & L Engineering20110—
+2K103192Navigation Marker, Reflective Marker SpheresIlumark GmbH20111—
+3K223864Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial…Brainlab AG20231—
+3K223288Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial…Brainlab AG20230—
+3K202609Instrument Clamps ElectromagneticStryker Corporation20200—
+3K193118TGS Guidewire and updated Scopis SoftwareStryker Ent20201—
+4K243698Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment…Brainlab AG20250—
+4K221098Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software…Stryker Corporation202201