510(k) Report

Devices descending from K090811

10 later devices reach Inspira HD, Model: NL1000 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K102677Bodytom NL 4000Neurologica Corporation20119—
+2K170238BodyTom EliteNeurologica Corporation, A Subsidiary of Samsung Electronics20174—
+2K142697NExCT 7Neurologica Corporation20140—
+2K131431Airo CT SystemMobius Imaging, LLC201321
+3K253450BodyTom Elite (NL4000)NeuroLogica Corp., a Samsung Company20260—
+3K213649BodyTom 64Neurologica Corporation20222—
+3K160126AIRO Computed Tomography (CT) X-ray SystemMobius Imaging201612
+4K242811BodyTom 64Neurologica Corporation, A Subsidiary of Samsung20251—
+4K180393AIRO Computed Tomography (CT) X-ray SystemMobius Imaging, LLC201805
+5K261125BodyTom 64 (NL4100); OmniTom Elite (NL5000)Samsung HME America, Inc., dba NeuroLogica Corp.20260—