Home / 510(k) Clearances / K250214

510(k) K250214

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) by Edan Instruments, Inc. — Product Code IYN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 20, 2025
Date Received
January 24, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
System, Imaging, Pulsed Doppler, Ultrasonic
Device Class
Class II
Regulation Number
892.1550
Review Panel
RA
Submission Type

Other clearances by Edan Instruments, Inc.

  • K251591 — Holter ECG and ABP system (HolterABP) (February 9, 2026)
  • K251268 — Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP) (December 23, 2025)
  • K241882 — Fetal & Maternal Monitor (F15A, F15A Air) (August 27, 2025)
  • K250179 — Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15) (July 29, 2025)
  • K240320 — Patient Monitor (RespArray) (June 28, 2024)
  • K232786 — Stimulation System (PA series, PR series, S series and Q series) (May 16, 2024)
  • K232962 — Patient Monitor (iX10, iX12, iX15) (April 19, 2024)
  • K233038 — Vital Signs monitor, Model: iM3s, iM3As, iM3Bs, iHM3s (March 8, 2024)
  • K232694 — Central Monitoring System (MFM-CMS) (February 5, 2024)
  • K230184 — Holter ECG and ABP System (September 25, 2023)

Other clearances for product code IYN

  • K260595 — Sonosite iLOOK Ultrasound System (March 10, 2026)
  • K253049 — Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, (February 11, 2026)
  • K253597 — Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound System (January 20, 2026)
  • K253370 — LOGIQ Totus (January 8, 2026)
  • K253366 — LOGIQ Fortis (January 7, 2026)
  • K252018 — HERA Z20 Diagnostic Ultrasound System; HERA Z20e Diagnostic Ultrasound System; H (January 5, 2026)
  • K251268 — Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP) (December 23, 2025)
  • K250959 — BioticsAI (December 22, 2025)
  • K252557 — Lumify Diagnostic Ultrasound System (December 22, 2025)
  • K252498 — Digital Color Doppler Ultrasound System (X11 Exp/X11 Elite/X11 Pro/X11 Plus/X11 (December 5, 2025)