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510(k) K232420

Zenition 30 by Philips Medical Systems Nederland B.V. — Product Code OWB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 16, 2024
Date Received
August 11, 2023
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Interventional Fluoroscopic X-Ray System
Device Class
Class II
Regulation Number
892.1650
Review Panel
RA
Submission Type

Interventional fluoroscopy

Other clearances by Philips Medical Systems Nederland B.V.

  • K253614 — EchoNavigator R5.0 (March 17, 2026)
  • 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)

Other clearances for product code OWB

  • K252229 — BELLIGER ACE (April 2, 2026)
  • K252099 — Trinias (March 24, 2026)
  • K253584 — Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension) (March 10, 2026)
  • K252500 — CARA System (February 20, 2026)
  • K251992 — ArmSure Fluoroscopic Positioning System (February 11, 2026)
  • K254186 — Azurion R3.1 (January 16, 2026)
  • K252068 — MC2 Portable X-ray System (December 22, 2025)
  • K251893 — SKAN C PULSAR (December 16, 2025)
  • K251199 — Allia Moveo (December 9, 2025)
  • K250241 — Cios Select (November 4, 2025)