510(k) Report

Devices descending from K042740

16 later devices reach Isc-1000 Pentax Confocal Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K093624Optiscan Model Optiscan CeisOptiscan Pty., Ltd.20100—
+1K061666Cellvizio with Confocal Miniprobes, Model F-600; Coloflex and GastroflexMauna Kea Technologies200613—
+1K051585F-400 SystemMauna Kea Technologies200513—
+2K133466Cellvizio 100 Series System with Confocal Miniprobes (TM)Mauna Kea Technologies20147—
+2K111047Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies, Inc.201112—
+3K172844Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies20176—
+3K150831Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies20157—
+3K141358Cellvizio 100 Series with System Confocal MiniprobesMauna Kea Technologies20149—
+3K132389Cellvizio 100 Series System and Cellvizio System with Confocal Miniprobes; Uroflex B and…Daniel & Daniel Consulting201410—
+4K193416Cellvizio I.V.E. with Confocal MiniprobesMauna Kea Technologies20200—
+4K191144Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies20202—
+4K183640Cellvizio 100 Series Confocal laser Imaging systems and their Confocal MiniprobesMauna Kea Technologies20194—
+4K160416CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal MiniprobesMauna Kea Technologies20167—
+5K243711Confocal Microprobe Imaging System (BrightP980); Confocal Microprobe Imaging System…Wuxi Hisky Medical Technologies Co., Ltd.20250—
+5K241275Histolog® Scanner (Hardware 2.4, Software 3.3)Samantree Medical SA20240—
+5K212322Cellvizio I.V.E. system with Confocal MiniprobesMauna Kea Technologies20210—