Cleared Traditional

K151887 - syngo VSim

K151887 is the FDA 510(k) clearance for syngo VSim by Siemens Medical Solutions USA, Inc.. It is a Class 2 Radiology device (product code MUJ) cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K151887 · Siemens Medical Solutions USA, Inc. · Radiology device
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Sep 2015
Decision
68d
Days
Class 2
Risk

K151887 is an FDA 510(k) clearance for the syngo VSim. Classified as System, Planning, Radiation Therapy Treatment (product code MUJ), Class II - Special Controls.

Submitted by Siemens Medical Solutions USA, Inc. (Mavern, US). The FDA issued a Cleared decision on September 16, 2015 after a review of 68 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Siemens Medical Solutions USA, Inc. devices

Submission Details

510(k) Number K151887 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 2015
Decision Date September 16, 2015
Days to Decision 68 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
39d faster than avg
Panel avg: 107d · This submission: 68d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Peers - MUJ System, Planning, Radiation Therapy Treatment

All 130
Devices cleared under the same product code (MUJ) and FDA review panel - the closest regulatory comparables to K151887.
Pinnacle Radiation Therapy Planning System
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syngo.via RT Image Suite
K162370 · Siemens Medical Solutions USA, Inc. · Oct 2016
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Leksell GammaPlan
K151666 · Elekta Instrument AB · Sep 2015
syngo.via RT Image Suite
K151380 · Siemens Medical Solutions USA, Inc. · Aug 2015
RT ELEMENTS, DOSE REVIEW, BRAIN METASTASES, ADAPTIVE HYBRID SURGERY ANALYSIS
K142108 · Brainlab AG · Dec 2014