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510(k) K251268

Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP) by Edan Instruments, Inc. — Product Code IYN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 2025
Date Received
April 24, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

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.

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  • K250214 — Acclarix AX8 Series Diagnostic Ultrasound System (Model: Acclarix AX7, Acclarix (February 20, 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)

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