Home / 510(k) Clearances / K242511

510(k) K242511

V5 Diagnostic Ultrasound System, H5 Diagnostic Ultrasound System, XV5 Diagnostic Ultrasound System, XH5 Diagnostic Ultrasound System, V4 Diagnostic Ultrasound System, H4 Diagnostic Ultrasound System, XV4 Diagnostic Ultrasound System, XH4 Diagnostic Ultrasound System by Samsung Medison Co., Ltd. — Product Code IYN

K242511 is an FDA 510(k) premarket notification submitted by Samsung Medison Co., Ltd. for the device "V5 Diagnostic Ultrasound System, H5 Diagnostic Ultrasound System, XV5 Diagnostic Ultrasound System, XH5 Diagnostic Ultrasound System, V4 Diagnostic Ultrasound System, H4 Diagnostic Ultrasound System, XV4 Diagnostic Ultrasound System, XH4 Diagnostic Ultrasound System". The FDA issued a decision of Substantially Equivalent on December 10, 2024. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. Samsung Medison Co., Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 10, 2024
Date Received
August 23, 2024
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.

  • K261412 — V8/XV8/XH8/H8/cV8/V8 ONE/XV8 ONE/XH8 ONE/H8 ONE/cV8 ONE Diagnostic Ultrasound Sy (July 28, 2026)
  • K254099 — EVO Q30 Diagnostic Ultrasound System; EVO Q20 Diagnostic Ultrasound System; EVO (March 27, 2026)
  • 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)
  • 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)

Other clearances for product code IYN

  • K261668 — Venue Go (August 7, 2026)
  • K262311 — Alturion Series Diagnostic Ultrasound System (August 4, 2026)
  • K261288 — Handheld Ultrasound Scanner (July 30, 2026)
  • K261835 — LOGIQ Focus (July 30, 2026)
  • K261412 — V8/XV8/XH8/H8/cV8/V8 ONE/XV8 ONE/XH8 ONE/H8 ONE/cV8 ONE Diagnostic Ultrasound Sy (July 28, 2026)
  • K261211 — Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagno (July 27, 2026)
  • K261081 — Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpro,C10MRpro) (July 23, 2026)
  • K261272 — ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePa (July 23, 2026)
  • K260667 — Alturion Series Diagnostic Ultrasound System (June 29, 2026)
  • K260844 — ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic Ult (June 16, 2026)

FDA data resources