Cleared Traditional

K260207 - Multimodality Simulation Workspace (MM Sim) (v1.0.0)

K260207 is an FDA 510(k) clearance for Multimodality Simulation Workspace (MM ..., manufactured by Philips Medical Systems Nederland B.V.. The device is a Class 2 Radiology device with product code MUJ cleared through the Traditional 510(k) pathway after a 124-day FDA review.

K260207 · Philips Medical Systems Nederland B.V. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2026
Decision
124d
Days
Class 2
Risk

K260207 is an FDA 510(k) clearance for the Multimodality Simulation Workspace (MM Sim) (v1.0.0). Classified as System, Planning, Radiation Therapy Treatment (product code MUJ), Class II - Special Controls.

Submitted by Philips Medical Systems Nederland B.V. (Best, NL). The FDA issued a Cleared decision on May 27, 2026 after a review of 124 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5050 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Philips Medical Systems Nederland B.V. devices

FDA 510(k) Submission Details - K260207

510(k) Number K260207 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 2026
Decision Date May 27, 2026
Days to Decision 124 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
17d slower than avg
Panel avg: 107d · This submission: 124d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MUJ Device Classification - Class 2, Special Controls

Product Code MUJ System, Planning, Radiation Therapy Treatment
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5050
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Consultant

Philips Medical Systems Technologies , Ltd.
Carmit Shmuel

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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