510(k) Report

Devices descending from K981153

19 later devices reach Osiris through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K052682AlignrtVision RT Limited2006181
+2K173926DORADOnova MR3TLap GmbH Laser Applikationen20180—
+2K123371Alignrt PlusVision RT Limited201385
+2K082582Sentinel, Model SP-001C-Rad Positioning AB20095—
+2K072171Gatect-RTVision RT Limited200712—
+2K063839PositionerC-Rad Positioning AB20070—
+3K181218AlignRT PlusVision Rt, Ltd.20187—
+3K120668SentinelC-Rad Positioning AB20121—
+3K113276CatalystC-Rad Positioning AB201221
+4K241937Klarity SGRT System (ARSG-E1A, ARSG-E3A)Klarity Medical & Equipment (GZ) Co., Ltd.20250—
+4K200435Catalyst+, Catalyst+ HDC-Rad Positioning AB202002
+4K200600SentinelC-Rad Positioning AB20200—
+4K193431AlignRT PlusVision Rt, Ltd.20206—
+5K203387AlignRT PlusVision Rt, Ltd.20215—
+6K212583AlignRT PlusVision Rt, Ltd.20214—
+7K233622AlignRT PlusVision Rt, Ltd.20242—
+7K232031LUNA 3DLap GmbH Laser Applikationen20240—
+8K253004LUNA 3DLap GmbH Laser Applikationen20260—
+8K253012AlignRT Plus (8.0)Vision Rt, Ltd.20260—