Cleared Traditional

K133655 - RADIANCE V2

K133655 is an FDA 510(k) clearance for RADIANCE V2, manufactured by Gmv Soluciones Globales Internet S.A.U.. The device is a Class 2 Radiology device with product code MUJ cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K133655 · Gmv Soluciones Globales Internet S.A.U. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2014
Decision
65d
Days
Class 2
Risk

K133655 is an FDA 510(k) clearance for the RADIANCE V2. Classified as System, Planning, Radiation Therapy Treatment (product code MUJ), Class II - Special Controls.

Submitted by Gmv Soluciones Globales Internet S.A.U. (Amsterdam, Noord Holland, NL). The FDA issued a Cleared decision on January 31, 2014 after a review of 65 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 Gmv Soluciones Globales Internet S.A.U. devices

FDA 510(k) Submission Details - K133655

510(k) Number K133655 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 2013
Decision Date January 31, 2014
Days to Decision 65 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
42d faster than avg
Panel avg: 107d · This submission: 65d
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 156
Devices cleared under the same product code (MUJ) and FDA review panel - the closest regulatory comparables to K133655.
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