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510(k) K243680

Neurovascular Insight V1.0 by Olea Medical S.A.S. — Product Code LLZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 25, 2025
Date Received
November 29, 2024
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 Olea Medical S.A.S.

  • K243681 — Neuro Insight V1.0 (July 23, 2025)
  • K223091 — CT Perfusion V1.0 (June 9, 2023)
  • K223532 — Olea S.I.A. Neurovascular V1.0 (June 6, 2023)
  • K230552 — MR DWI/FLAIR Measurement V1.0 (April 26, 2023)
  • K223502 — MR Diffusion Perfusion Mismatch V1.0 (January 13, 2023)
  • K221426 — Functional MR V1.0 (July 6, 2022)
  • K211431 — breastscape v1.0 (August 2, 2021)
  • K152602 — Olea Sphere V3.0 (March 3, 2016)
  • K132095 — OLEA SPHERE (December 26, 2013)
  • K120196 — OLEA SPHERE (April 19, 2012)

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)