510(k) Report

Devices descending from K915470

17 later devices reach Optima Nuclear Tomography Stystem through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K051855VentriGe Medical Systems F.I. Haifa200533
+1K962738Millennium MT and Millennium MG Nuclear Medicine SystemsGE Medical Systems199616Class I
+2K080124Ventri 1.1Ge Medical Systems F.I. Haifa200822
+2K022240Mobile Millennium MG SystemGe Medical Systems, Inc.200211—
+3K212004MyoSPECT, MyoSpect ESGE Healthcare202101
+3K090811Inspira HD, Model: NL1000Neurologica Corporation200910—
+3K083504GE Discovery NM/CT 570CGe Medical Systems F.I. Haifa200801
+4K102677Bodytom NL 4000Neurologica Corporation20119—
+5K170238BodyTom EliteNeurologica Corporation, A Subsidiary of Samsung Electronics20174—
+5K142697NExCT 7Neurologica Corporation20140—
+5K131431Airo CT SystemMobius Imaging, LLC201321
+6K253450BodyTom Elite (NL4000)NeuroLogica Corp., a Samsung Company20260—
+6K213649BodyTom 64Neurologica Corporation20222—
+6K160126AIRO Computed Tomography (CT) X-ray SystemMobius Imaging201612
+7K242811BodyTom 64Neurologica Corporation, A Subsidiary of Samsung20251—
+7K180393AIRO Computed Tomography (CT) X-ray SystemMobius Imaging, LLC201805
+8K261125BodyTom 64 (NL4100); OmniTom Elite (NL5000)Samsung HME America, Inc., dba NeuroLogica Corp.20260—