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510(k) K254186

Azurion R3.1 by Philips Medical Systems B.V. — Product Code OWB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 16, 2026
Date Received
December 23, 2025
Clearance Type
Special
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 B.V.

  • K251827 — Azurion R3.1 (October 24, 2025)
  • K212704 — Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasoun (September 24, 2021)
  • K211597 — EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound (September 8, 2021)
  • K210560 — Page Writer TC20 Cardiograph, Page Writer TC30 Cardiograph, Page Writer TC50 Car (June 30, 2021)
  • K191738 — PageWriter TC20 Cardiograph, PageWriter TC30 Cardiograph, PageWriter TC50 Cardio (September 29, 2020)
  • K192875 — Philips Biosensor BX100 (April 16, 2020)
  • K183387 — M3290B Patient Information Center iX (August 6, 2019)
  • K180017 — MX40 Release C.01 (July 24, 2018)
  • K172226 — MX40 Release B.07 (November 9, 2017)
  • K163584 — M3290B Philips IntelliVue Information Center iX (July 7, 2017)

Other clearances for product code OWB

  • 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)
  • 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)
  • K251827 — Azurion R3.1 (October 24, 2025)
  • K251602 — Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (October 10, 2025)
  • K251523 — Cios Spin (July 29, 2025)