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
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
K252433sonioSonio Detect (v3)March 16, 2026
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