510(k) Report

Devices descending from K171255

14 later devices reach Monteris Medical NeuroBlate System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K201056NeuroBlate SystemMonteris Medical, Inc.20209—
+1K182036NeuroBlate SystemMonteris Medical,201811—
+1K172881NeuroBlate SystemMonteris Medical,201713—
+2K231061NeuroBlate SystemMonteris Medical,20236—
+2K222983NeuroBlate Fusion-S Software V3.17Monteris Medical,20237—
+2K211269Visualase MRI-Guided Laser Ablation System (SW 3.4)Medtronic Navigation, Inc.202271
+2K193375NeuroBlate SystemMonteris Medical,202010—
+2K173305NeuroBlate SystemMonteris Medical,201712—
+3K253391Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator…Medtronic Navigation, Inc.20260—
+3K250307Visualase V2 MRI-guided Laser Ablation System (9736422)Medtronic Navigation20251—
+3K240877Monteris Medical NeuroBlate SystemMonteris Medical,20245—
+4K262315NeuroBlate SystemMonteris Medical20260—
+4K260976NeuroBlate SystemMonteris Medical20261—
+4K251298Mobile Laser Unit (1001-N2); Thermoguide Workstation (1100-N1); Laser Applicator…Clinical Laserthermia Systems, AB20250—