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510(k) K203104

IBM iConnect Access by Merge Healthcare Incorporated — Product Code LLZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 26, 2021
Date Received
October 14, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Image Processing, Radiological
Device Class
Class II
Regulation Number
892.2050
Review Panel
RA
Submission Type

Other clearances by Merge Healthcare Incorporated

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  • 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)

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  • K253486 — SKIA-Head (Model: SKIA-ST00) (February 23, 2026)
  • K260205 — AS Software Version Asera (February 19, 2026)
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  • K253927 — LiveMedica Enterprise PACS (February 6, 2026)