Home / 510(k) Clearances / K191216

510(k) K191216

Voxel Dosimetry™ v1.0 by Hermes Medical Solutions AB — Product Code LLZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 17, 2019
Date Received
May 6, 2019
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 Hermes Medical Solutions AB

  • K252477 — Hybrid Viewer (00859873006240) (September 9, 2025)
  • K243919 — Voxel Dosimetry (00859873006226) (July 30, 2025)
  • K241364 — Hybrid Viewer (00859873006189) (November 8, 2024)
  • K202882 — Affinity (December 23, 2020)
  • K193152 — Affinity (February 14, 2020)
  • K181468 — Hybrid3D (October 25, 2018)
  • K171719 — Hybrid3D (November 21, 2017)
  • K171681 — Hermes Medical Imaging Suite v5.7 (November 21, 2017)
  • K163687 — OLINDA EXM (July 19, 2017)
  • K163394 — Hybrid3D (May 22, 2017)

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)