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510(k) K243012

MIM – Symphony HDR Fusion by Mim Software, Inc. — Product Code LLZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 23, 2024
Date Received
September 27, 2024
Clearance Type
Special
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 Mim Software, Inc.

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  • K250035 — Contour ProtégéAI+ (February 3, 2025)
  • K233620 — MIM - Centiloid Scaling (May 20, 2024)
  • K232862 — MIM – Monte Carlo Dosimetry (May 13, 2024)
  • K232514 — MIM – Dose Analysis (May 6, 2024)
  • K231765 — Contour ProtégéAI (November 8, 2023)
  • K223774 — Contour ProtégéAI (April 6, 2023)
  • K223800 — MIM – Additional Tracers (January 17, 2023)
  • K220256 — MIM-Ablation (October 7, 2022)
  • K213976 — Contour ProtégéAI (February 3, 2022)

Other clearances for product code LLZ

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  • 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)