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510(k) K250181

AV Viewer by Philips Medical Systems Nederland B.V. — Product Code LLZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 15, 2025
Date Received
January 22, 2025
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 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)
  • 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)
  • K242001 — Philips VSC-MEDlib (April 4, 2025)

Other clearances for product code LLZ

  • K260479 — TheraSphere 360™ Y-90 Management Platform (March 13, 2026)
  • K253111 — Aeka Imaging (March 13, 2026)
  • K251964 — Mimics Thoracic Planner (March 12, 2026)
  • K253551 — VELYS™ Hip Navigation (March 6, 2026)
  • K253486 — SKIA-Head (Model: SKIA-ST00) (February 23, 2026)
  • K260205 — AS Software Version Asera (February 19, 2026)
  • K253927 — LiveMedica Enterprise PACS (February 6, 2026)
  • K251577 — LAIA XR (February 6, 2026)
  • K253639 — View (January 8, 2026)
  • K253784 — 3DICOM MD Cloud (January 8, 2026)