510(k) Report

Devices descending from K100468

4 later devices reach Zeiss Infrared 800 with Flow 800 Option through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231986Modus IRSynaptive Medical, Inc.20240—
+1K231075Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option)Carl Zeiss Meditec, Inc.20230—
+1K202391DIR 800Aesculap, Inc.20211—
+2K243077Affirm 800Digital Surgery Systems, Inc. (D.B.A True Digital Surgery)20250—