510(k) Report

Devices descending from K954255

19 later devices reach Philips Tomoscan SR 8000 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K991278Philips Tomoscan AV-NTPhilips Medical Systems North America, Inc.199917—
+1K964318Philips Tomoscan AV Expander UpgradePhilips Medical Systems North America, Inc.19970—
+2K014240ProntoHitachi Medical Systems America, Inc.200216—
+3K040902Hitachi PrestoHitachi Medical Systems America, Inc.2004154
+4K091103Guideshot Option for CXR4 and Eclos CT SystemsHitachi Medical Systems America, Inc.20091—
+4K071806Eclos Computed Tomography X-Ray SystemHitachi Medical Systems America, Inc.2007121
+4K053148CXR16Hitachi Medical Systems America, Inc.20060—
+4K042428SCEPTREP3 Pet/CTHitachi Medical Systems America, Inc.200402
+5K113341Guideshot Option, Scenaria Whole-Body X-Ray CT SystemHitachi Medical Systems America, Inc.20120—
+5K102677Bodytom NL 4000Neurologica Corporation20119—
+6K170238BodyTom EliteNeurologica Corporation, A Subsidiary of Samsung Electronics20174—
+6K142697NExCT 7Neurologica Corporation20140—
+6K131431Airo CT SystemMobius Imaging, LLC201321
+7K253450BodyTom Elite (NL4000)NeuroLogica Corp., a Samsung Company20260—
+7K213649BodyTom 64Neurologica Corporation20222—
+7K160126AIRO Computed Tomography (CT) X-ray SystemMobius Imaging201612
+8K242811BodyTom 64Neurologica Corporation, A Subsidiary of Samsung20251—
+8K180393AIRO Computed Tomography (CT) X-ray SystemMobius Imaging, LLC201805
+9K261125BodyTom 64 (NL4100); OmniTom Elite (NL5000)Samsung HME America, Inc., dba NeuroLogica Corp.20260—