510(k) Report

Devices descending from K150441

9 later devices reach Volcano iFR Modality, iFR Scout feature through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K170133FFR V2.5Philips Volcano201751
+1K153369SW v3.5 Install Kit, CORE Mobile, SW v3.5 Install Kit, CORE, SW v3.5 Install Kit, s5izVolcano Corporation20152—
+2K173860s5 Intravascular Ultrasound Imaging and Pressure Systems, s5i Intravascular Ultrasound…Volcano Corporation20184—
+2K172455CORE M2 Vascular System, CORE M2 Software v4.2 Upgrade Kit, CORE M2 Software v4.2…Volcano Corporation201701
+2K170385CORE M2 Vascular SystemVolcano Corporation20171—
+3K233948Provisio™ SLT IVUS™ SystemProvisio Medical, Inc.20240—
+3K190078IntraSightVolcano Corporation20192—
+4K253714IntraSight PlusPhilips Image Guided Therapy Corporation202601
+4K203719IntraSight MobileVolcano Corporation202101