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
K260595fujifilm sonositeSonosite iLOOK Ultrasound SystemMarch 10, 2026
K253049shenzhen mindray bio-medical electronics coResona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, February 11, 2026
K253597canon medical systems corporationAplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound SystemJanuary 20, 2026
K253370ge medical systems ultrasound and primary care diagnosticsLOGIQ TotusJanuary 8, 2026
K253366ge medical systems ultrasound and primary care diagnosticsLOGIQ FortisJanuary 7, 2026
K252018samsung medison coHERA Z20 Diagnostic Ultrasound System; HERA Z20e Diagnostic Ultrasound System; HJanuary 5, 2026
K251268edan instrumentsDiagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP)December 23, 2025
K250959bioticsaiBioticsAIDecember 22, 2025
K252557philips ultrasoundLumify Diagnostic Ultrasound SystemDecember 22, 2025
K252498sonoscape medicalDigital Color Doppler Ultrasound System (X11 Exp/X11 Elite/X11 Pro/X11 Plus/X11 December 5, 2025
K250791asustek computerASUS Ultrasound Imaging System (LU800 series)December 4, 2025
K251601shenzhen mindray bio-medical electronics coHepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus7T/HepatusDecember 3, 2025
K253310esaote7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)November 25, 2025
K252328ge medical systems ultrasound and primary care diagnosticsVoluson Expert 18; Voluson Expert 20; Voluson Expert 22November 24, 2025
K253487siemens medical solutions usaACUSON Maple Diagnostic Ultrasound System; ACUSON Maple Select Diagnostic UltrasNovember 17, 2025
K253457siemens medical solutions usaACUSON Juniper Diagnostic Ultrasound System; ACUSON Juniper Select Diagnostic UlNovember 13, 2025
K251853shenzhen mindray bio-medical electronics coConsona N5, Consona N5 Pro, Consona N5 Super, Consona N5 Exp, Consona ER, ConsonNovember 7, 2025
K253448fujifilm sonositeSonosite MT Ultrasound SystemNovember 3, 2025
K252074canon medical systems corporationAplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound SystemOctober 31, 2025
K251963ge medical systems ultrasound and primary care diagnosticsLOGIQ E10sOctober 29, 2025