510(k) Report

Devices descending from DEN170092

6 later devices reach Fluobeam 800 Clinic Imaging Device used with Fluocase 800 Control System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191371MolecuLight i:XMolecuLight, Inc.20195—
+2K251678Swift Ray 1Swift Medical, Inc.20260—
+2K213840MolecuLight I:XMolecuLight, Inc.20220—
+2K211901MolecuLightDXMolecuLight, Inc.20211—
+2K210882MolecuLight I:XMolecuLight, Inc.20211—
+3K242669SnapshotGLO (KB100)Kent Imaging, Inc.202501