Cleared Traditional

K102915 - VIEWRAY TREATMENT PLANNING AND DELIVERY...

K102915 is an FDA 510(k) clearance for VIEWRAY TREATMENT PLANNING AND DELIVERY..., manufactured by Viewray, Incorporated. The device is a Class 2 Radiology device with product code MUJ cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K102915 · Viewray, Incorporated · Radiology device
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Jan 2011
Decision
103d
Days
Class 2
Risk

K102915 is an FDA 510(k) clearance for the VIEWRAY TREATMENT PLANNING AND DELIVERY SYSTEM. Classified as System, Planning, Radiation Therapy Treatment (product code MUJ), Class II - Special Controls.

Submitted by Viewray, Incorporated (Oakwood Village, US). The FDA issued a Cleared decision on January 12, 2011 after a review of 103 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 Viewray, Incorporated devices

FDA 510(k) Submission Details - K102915

510(k) Number K102915 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 2010
Decision Date January 12, 2011
Days to Decision 103 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 107d · This submission: 103d
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 Peers - MUJ System, Planning, Radiation Therapy Treatment

All 145
Devices cleared under the same product code (MUJ) and FDA review panel - the closest regulatory comparables to K102915.
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