510(k) K260207

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

K260207 is an FDA 510(k) premarket notification submitted by Philips Medical Systems Nederland B.V. for the device "Multimodality Simulation Workspace (MM Sim) (v1.0.0)". The FDA issued a decision of Substantially Equivalent on May 27, 2026. The device falls under product code MUJ (System, Planning, Radiation Therapy Treatment), a Class II device regulated under 21 CFR 892.5050. Philips Medical Systems Nederland B.V. has at least 10 other 510(k) clearances on record.

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