510(k) Report

Devices descending from K010509

11 later devices reach Cedars-Sinai BPGS and Moco through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K100714CSMC Cardiac Suite-Nuclear Medicine Software Applicaton Model 2010-01Cedars-Sinai Medical Center20110—
+1K082904Stasys Motion Correction SoftwareDigirad Corp.20080—
+1K052430Cardius-1, Cardius-2, Cardius-3, 2020TC Spect Imaging SystemDigirad Corp.20057—
+1K023110Cedars-Sinai Motion Correction (Moco) Software, Model 111005Digirad Corp.20029—
+2K082368Cardius-1, -2, -3, and Cardius 1,2,3 Xpo Spect Imaging Systems, 2020TC Spect Imaging…Digirad Corp.20081—
+2K070542Cardius 1, 2 and 3 Xpo and 2020TC Spect Imaging SystemsDigirad Corp.20076—
+3K100838Ergo Imaging SystemDigirad Corp.20102—
+3K083649Cardius 3 X-ActDigirad Corp.20090—
+3K072191Clearvision Nuclear Medicine Imaging SystemGvi Technology Partners20070—
+4K123408Ergo Imaging SystemDigirad Corp.20130—
+4K110384Dilon 6800 Acella (Acella)Dilon Technologies, Inc.20110—