510(k) Report

Devices descending from K170133

5 later devices reach FFR V2.5 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173860s5 Intravascular Ultrasound Imaging and Pressure Systems, s5i Intravascular Ultrasound…Volcano Corporation20184—
+2K233948Provisio™ SLT IVUS™ SystemProvisio Medical, Inc.20240—
+2K190078IntraSightVolcano Corporation20192—
+3K253714IntraSight PlusPhilips Image Guided Therapy Corporation202601
+3K203719IntraSight MobileVolcano Corporation202101