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510(k) K260207

Multimodality Simulation Workspace (MM Sim) (v1.0.0) by Philips Medical Systems Nederland B.V. — Product Code MUJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 27, 2026
Date Received
January 23, 2026
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Planning, Radiation Therapy Treatment
Device Class
Class II
Regulation Number
892.5050
Review Panel
RA
Submission Type

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  • 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)
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  • K250648 — Philips iCT CT system (June 27, 2025)

Other clearances for product code MUJ

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  • K252304 — syngo.via RT Image Suite VC10 (March 18, 2026)
  • K260308 — TrueFit Bolus (February 19, 2026)
  • K252002 — Monaco RTP System (6.3) (February 19, 2026)
  • K253091 — ART-Plan+ (v3.1.0) (December 23, 2025)
  • K252109 — RayStation (2024A SP3) (December 22, 2025)
  • K252863 — ClearCalc Model RADCA V2.6 (December 19, 2025)
  • K250963 — PlanOne 1 (November 20, 2025)