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510(k) K233326

Merge Hemo, Model RCSV2 by Merge Healthcare Incorporated — Product Code DQK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 21, 2024
Date Received
September 29, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Computer, Diagnostic, Programmable
Device Class
Class II
Regulation Number
870.1425
Review Panel
CV
Submission Type

Other clearances by Merge Healthcare Incorporated

  • K250301 — Merge Universal Viewer (MUV) (April 14, 2025)
  • K203104 — IBM iConnect Access (January 26, 2021)
  • K192455 — Merge PACS (October 17, 2019)
  • K192276 — Merge Cardio (September 20, 2019)
  • K182290 — IBM iConnect Access (September 25, 2018)
  • K173475 — Merge PACS (December 8, 2017)
  • K152864 — Merge Hemo (April 7, 2016)

Other clearances for product code DQK

  • K253861 — ACORYS MAPPING SYSTEM (April 13, 2026)
  • K253473 — Synchrony (April 1, 2026)
  • K253186 — HemoSphere Nano Monitor (HSNANO1) (February 24, 2026)
  • K252972 — CARTO™ 3 EP Navigation System V8.4 (February 20, 2026)
  • K254089 — IOPS Visionary System (MC-3); IOPS Viewpoint Simple Curve Catheter, 75cm (C00751 (February 17, 2026)
  • K251591 — Holter ECG and ABP system (HolterABP) (February 9, 2026)
  • K251218 — SafeBeat Rx App (February 6, 2026)
  • K252164 — NorthStar™ Mapping System (January 28, 2026)
  • K254085 — CARTO™ 3 EP Navigation System V9.0 with PIU Plus (January 18, 2026)
  • K253733 — STAR Apollo™ Mapping System (December 19, 2025)