510(k) Report

Devices descending from K970943

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K071364Microtargeting Guideline 4000FHC, Inc.200731
+1K042208Isis Mer System/Elekta Mer SystemInomed Medizintechnik GmbH20050—
+1K993622Neurotrek Physiological Navigation System for NeurosurgeryAlpha Omega, Ltd.20004—
+2K183123microTargeting Guideline 4000 5.0 SystemFHC, Inc.201811
+2K140680Leadpoint Focus Workststion, Leadpoint Focus Notebook SystemAlpine Biomed Aps20140—
+3K250094Atlas Stim Headbox (NK) (31-0601-0077); Atlas Stim Headbox (Touchproof) (31-0601-0089)…Neuralynx, Inc.20250—