510(k) Report

Devices descending from K040902

15 later devices reach Hitachi Presto through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K091103Guideshot Option for CXR4 and Eclos CT SystemsHitachi Medical Systems America, Inc.20091—
+1K071806Eclos Computed Tomography X-Ray SystemHitachi Medical Systems America, Inc.2007121
+1K053148CXR16Hitachi Medical Systems America, Inc.20060—
+1K042428SCEPTREP3 Pet/CTHitachi Medical Systems America, Inc.200402
+2K113341Guideshot Option, Scenaria Whole-Body X-Ray CT SystemHitachi Medical Systems America, Inc.20120—
+2K102677Bodytom NL 4000Neurologica Corporation20119—
+3K170238BodyTom EliteNeurologica Corporation, A Subsidiary of Samsung Electronics20174—
+3K142697NExCT 7Neurologica Corporation20140—
+3K131431Airo CT SystemMobius Imaging, LLC201321
+4K253450BodyTom Elite (NL4000)NeuroLogica Corp., a Samsung Company20260—
+4K213649BodyTom 64Neurologica Corporation20222—
+4K160126AIRO Computed Tomography (CT) X-ray SystemMobius Imaging201612
+5K242811BodyTom 64Neurologica Corporation, A Subsidiary of Samsung20251—
+5K180393AIRO Computed Tomography (CT) X-ray SystemMobius Imaging, LLC201805
+6K261125BodyTom 64 (NL4100); OmniTom Elite (NL5000)Samsung HME America, Inc., dba NeuroLogica Corp.20260—