510(k) Report

Devices descending from K183599

7 later devices reach Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221257SpectraWAVE Imaging SystemSpectrawave, Inc.20234—
+1K213303Makoto Intravascular Imaging System, TVC-MC10/TVC-MC10i, Dualpro IVUS + NIRS Imaging…Infraredx, Inc.20211—
+2K253101HyperVue™ Imaging System - IntegratedSpectrawave, Inc.20250—
+2K243016Starlight Imaging CatheterSpectrawave, Inc.20250—
+2K241576Makoto Intravascular Imaging System™ (VC-MC10 / TVC-MC10i); Dualpro™ IVUS+NIRS Imaging…Infraredx, Inc.20250—
+2K230691HyperVue™ Imaging SystemSpectrawave, Inc.20231—
+3K251198HyperVue™ SoftwareSpectrawave, Inc.20250—