510(k) Report

Devices descending from K022428

4 later devices reach Quantitative Blood Pool Spect (QBS) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K040326Autoquant PlusAdac Laboratories20043—
+2K213731EFAI CARDIOSUITE SPECT Myocardial Perfusion Agile WorkflowsEver Fortune.Ai, Co., Ltd.20220—
+2K060020Autoquant PlusAdac Laboratories20061—
+3K100714CSMC Cardiac Suite-Nuclear Medicine Software Applicaton Model 2010-01Cedars-Sinai Medical Center20110—