System, Imaging, Pulsed Doppler, Ultrasonic
Edan Instruments, Inc.'s record for this product code
Recent MDR events
0 adverse event reports on file
No MDR events on file for Edan Instruments, Inc. under this product code.
Recalls
0 recall events for this product code
No recalls on file for Edan Instruments, Inc. under this product code.
510(k) clearances
13 clearances for this product code
- K251268Dec 23, 2025
Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP)
- K250214Feb 20, 2025
Acclarix AX8 Series Diagnostic Ultrasound System (Model: Acclarix AX7, Acclarix AX8, Acclarix AX75, Acclarix AX78, Acclarix AX8 Exp, Acclarix AX8 Super), Acclarix AX9 Series Diagnostic Ultrasound Szystem (Model: Acclarix AX9 Basic, Acclarix AX9, Acclarix AX9 Exp, Acclarix AX9 Super, Acclarix AX85, Acclarix AX88)
- K202856Jan 25, 2021
Diagnostic Ultrasound System, Models: Acclarix AX3, Acclarix AX3 Exp, Acclarix AX3 Super, Acclarix AX25, Acclarix AX28, Acclarix AX2, Acclarix AX2 Exp, Acclarix AX2 Super, Acclarix AX15, Acclarix AX18, Acclarix LX3, Acclarix LX3 Exp, Acclarix LX3 Super, Acclarix LX25 and Acclarix LX28
- K192879May 21, 2020
Acclarix AX8 Diagnostic Ultrasound System / Acclarix LX9 Series Diagnostic Ultrasound System
- K180862May 24, 2018
Acclarix LX8 Diagnostic Ultrasound System, Acclarix AX8 Diagnostic Ultrasound System
- K180408Apr 13, 2018
U60 Diagnostic Ultrasound System
- K173003Nov 15, 2017
U50 Diagnostic Ultrasound System
- K172380Sep 29, 2017
U2 Diagnostic Ultrasound System
- K171900Aug 18, 2017
Acclarix AX4 Diagnostic Ultrasound System
- K162055Jan 31, 2017
Acclarix LX8 Diagnostic Ultrasound System