510(k) Report

Devices descending from K152124

7 later devices reach Tempus IC2 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K152645Dictum HealthDictum Health, Inc.20166—
+2K170798Dictum HealthDictum Health, Inc.20175—
+3K192004Eko Analysis SoftwareEko Devices, Inc.20204—
+4K213794Eko Murmur Analysis Software (EMAS)Eko Devices, Inc.20223—
+5K251494Eko Foundation Analysis Software with Transformers (EFAST)Eko Health, Inc.20250—
+5K240901StethophoneSparrow Acoustics, Inc.20241—
+6K252595Stethophone ProSparrow Acoustics, Inc.20250—