510(k) Report

Devices descending from K013633

211 later devices reach Ssa-770A, Aplio Ultrasound System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+16K233977VelacurSonic Incytes20241—
+16K223902FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630)Echosens20231—
+16K213102ES1 SystemE-Scopics20223—
+16K212035FibroScan 230Echosens20215—
+17K260748ES-SeriesE-Scopics20260—
+17K251728Velacur One (LI-1100)Sonic Incytes Medical Corp20250—
+17K233401Portable Liver Elastography Ultrasound Diagnostic System (Liverscan Mobile)Eieling Technology Limited20242—
+17K232336ES Series V2E-Scopics20232—
+18K260589ES-SeriesE-Scopics20260—
+18K253221Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro)Eieling Technology (Shenzhen) Limited20260—
+18K242496Portable Liver Elastography Ultrasound Diagnostic System (Liverscan C)Eieling Technology (Shenzhen) Limited20240—