IYN — System, Imaging, Pulsed Doppler, Ultrasonic Class II

FDA Device Classification

Classification Details

Product Code
IYN
Device Class
Class II
Regulation Number
892.1550
Submission Type
Review Panel
RA
Medical Specialty
Radiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K260844siemens medical solutions usaACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic UltJune 16, 2026
K260748e-scopicsES-SeriesJune 9, 2026
K260680philips ultrasoundEPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic UltrasoundMay 27, 2026
K260123philips ultrasoundEPIQ Series Diagnostic Ultrasound SystemMay 27, 2026
K260398ge medical systems ultrasound and primary care diagnosticsLOGIQ eMay 26, 2026
K253949chison medical technologies coSonoPort Series Digital Color Doppler Ultrasound System (SonoPort 1, SonoPort 1 May 22, 2026
K253720wuhan united imaging healthcare couSONIQUE Nova, uSONIQUE Nova Elite, uSONIQUE Vita, uSONIQUE Vita Elite, uSONIQUEMay 21, 2026
K253716wuhan united imaging healthcare couSONIQUE Genesis, uSONIQUE Genesis Pro, uSONIQUE Genesis Elite, uSONIQUE GenesisMay 15, 2026
K254028sonoscape medicalDigital Color Doppler Ultrasound System (Autra RS, Autra 90, Autra Senior, AutraMay 15, 2026
K260111mytech intelligence (shenzhen) coPalmtop Ultrasound Diagnostic System (MT10P/MT10)May 14, 2026
K260846shenzhen mindray bio-medical electronics coDiagnostic Ultrasound System (MU9);Diagnostic Ultrasound System (MU9S);DiagnostiMay 11, 2026
K252558philips ultrasoundLumify Diagnostic Ultrasound SystemMay 5, 2026
K261132healium intelliscan corporationHealium Intelliscan LX192LCMay 5, 2026
K260589e-scopicsES-SeriesApril 29, 2026
K253288esaote6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)April 6, 2026
K252709xuzhou yongkang electronic science technology coWireless Probe Type Ultrasound ScannerApril 2, 2026
K253595philips ultrasoundEPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound March 27, 2026
K254099samsung medison coEVO Q30 Diagnostic Ultrasound System; EVO Q20 Diagnostic Ultrasound System; EVO March 27, 2026
K252148butterfly networkButterfly Gestational Age ToolMarch 27, 2026
K260673ge medical systems ultrasound and primary care diagnosticsLOGIQ Vita; LOGIQ Vita Pro; LOGIQ Vita Express; LOGIQ Vita Plus; LOGIQ Vita PoweMarch 24, 2026