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510(k) K211824

HERA W9, HERA W10 Diagnostic Ultrasound System by Samsung Medison Co., Ltd. — Product Code IYN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 9, 2021
Date Received
June 14, 2021
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 Samsung Medison Co., Ltd.

  • K252018 — HERA Z20 Diagnostic Ultrasound System; HERA Z20e Diagnostic Ultrasound System; H (January 5, 2026)
  • K250999 — V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic (July 18, 2025)
  • K243702 — V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic (February 12, 2025)
  • K242511 — V5 Diagnostic Ultrasound System, H5 Diagnostic Ultrasound System, XV5 Diagnostic (December 10, 2024)
  • K242444 — HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound System (November 27, 2024)
  • K241971 — HERA Z20, R20, HERA Z30, R30 Diagnostic Ultrasound System (October 11, 2024)
  • K241302 — SonoSync (August 23, 2024)
  • K240631 — V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic Ultrasound System (June 21, 2024)
  • K240516 — RS85 Diagnostic Ultrasound System (June 12, 2024)
  • K233112 — HM70 EVO Diagnostic Ultrasound System (December 21, 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)