Home / 510(k) Clearances / K170078

510(k) K170078

Medisono Color Doppler Ultrasound System, models P11 Portable, P11 EXPERT Portable, P12 Trolley, P12 Expert, P25 Trolley, and P25 Expert Trolley by Medisono, LLC — Product Code IYN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 17, 2017
Date Received
January 9, 2017
Clearance Type
Abbreviated
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 Medisono, LLC

  • K231659 — MS55 Plus Digital Color Doppler Ultrasound System (MS55); P25 Expert Digital Col (February 15, 2024)
  • K163688 — Medisono Ultrasonic Diagnostic Imaging System, models P1, P3, and P10 (February 23, 2017)

Other clearances for product code IYN

  • K253288 — 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85) (April 6, 2026)
  • K252709 — Wireless Probe Type Ultrasound Scanner (April 2, 2026)
  • K253595 — EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound (March 27, 2026)
  • K254099 — EVO Q30 Diagnostic Ultrasound System; EVO Q20 Diagnostic Ultrasound System; EVO (March 27, 2026)
  • K252148 — Butterfly Gestational Age Tool (March 27, 2026)
  • K260673 — LOGIQ Vita; LOGIQ Vita Pro; LOGIQ Vita Express; LOGIQ Vita Plus; LOGIQ Vita Powe (March 24, 2026)
  • K252433 — Sonio Detect (v3) (March 16, 2026)
  • 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)