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510(k) K233853

LumiGuide Wire; LumiGuide Equipment R2.0; LumiGuide 3D Hub by Philips Medical Systems Nederland B.V. — Product Code DQK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 14, 2024
Date Received
December 5, 2023
Clearance Type
Special
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 Philips Medical Systems Nederland B.V.

  • K260169 — AV Cardiac CT (March 5, 2026)
  • K253648 — Ingenia, Ingenia CX, Ingenia Elition S/X, Ingenia Ambition S/X, BlueSeal SE/XE/Q (February 23, 2026)
  • K253735 — AV Vascular (January 22, 2026)
  • K254190 — dS Base 1.5T; dS Base 3.0T; dS Head 1.5T; dS Head 3.0T; dS HeadNeck 1.5T; dS Hea (January 14, 2026)
  • K252645 — LumiGuide Equipment R2.1; LumiGuide Wire; LumiGuide 3D Hub (October 24, 2025)
  • K251215 — Philips IntelliSpace Cardiovascular (October 2, 2025)
  • K250181 — AV Viewer (July 15, 2025)
  • K251808 — Achieva; Intera; Ingenia 1.5T; Ingenia 3.0T; Ingenia 1.5T CX; Ingenia 3.0T CX; I (July 11, 2025)
  • K250648 — Philips iCT CT system (June 27, 2025)
  • K251397 — Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, BlueSeal, MR 5300 and MR (June 4, 2025)

Other clearances for product code DQK

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  • 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)
  • K252533 — HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1) (December 18, 2025)
  • K253141 — DeepRhythmAI (December 11, 2025)