FDA 510(k)

Multimodality Simulation Workspace (MM Sim) (v1.0.0)

K-Nummer: K260207 · 2026-05-27

AntragstellerPhilips Medical Systems Nederland B.V.

Entscheidungsdatum2026-05-27

ProduktcodeMUJ

BeratungsausschussRA

EntscheidungSubstantially Equivalent

Produktübersicht

Multimodality Simulation Workspace (MM Sim) (v1.0.0) is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems Nederland B.V.. It received FDA 510(k) clearance on 2026-05-27 under 510(k) number K260207. The device is classified under product code MUJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the Multimodality Simulation Workspace (MM Sim) (v1.0.0)?

Multimodality Simulation Workspace (MM Sim) (v1.0.0) is a medical device that received FDA 510(k) clearance on 2026-05-27. The listed applicant is Philips Medical Systems Nederland B.V.. The 510(k) number is K260207.

When did Multimodality Simulation Workspace (MM Sim) (v1.0.0) receive FDA 510(k) clearance?

Multimodality Simulation Workspace (MM Sim) (v1.0.0) received FDA 510(k) clearance on 2026-05-27, under 510(k) number K260207.

Who is the listed applicant for Multimodality Simulation Workspace (MM Sim) (v1.0.0)?

The FDA 510(k) record lists Philips Medical Systems Nederland B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Multimodality Simulation Workspace (MM Sim) (v1.0.0)?

The FDA product code for Multimodality Simulation Workspace (MM Sim) (v1.0.0) is MUJ.

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