Cleared Traditional

Radiance V3 (K153368) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K153368 · Gmv Soluciones Globales Internet S.A.U. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2016
Decision
85d
Days
Class 2
Risk

K153368 is an FDA 510(k) clearance for the Radiance V3. Classified as System, Planning, Radiation Therapy Treatment (product code MUJ), Class II - Special Controls.

Submitted by Gmv Soluciones Globales Internet S.A.U. (Madrid, ES). The FDA issued a Cleared decision on February 16, 2016 after a review of 85 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

Submission Details

510(k) Number K153368 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 2015
Decision Date February 16, 2016
Days to Decision 85 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
22d faster than avg
Panel avg: 107d · This submission: 85d
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 114
Devices cleared under the same product code (MUJ) and FDA review panel - the closest regulatory comparables to K153368.
Eclipse Treatment Planning System
K170969 · Varian Medical Systems, Inc. · Jul 2017
Pinnacle Radiation Therapy Planning System
K170086 · Philips Medical Systems (Cleveland), Inc. · Feb 2017
syngo.via RT Image Suite
K162370 · Siemens Medical Solutions USA, Inc. · Oct 2016
Eclipse Treatment Planning System
K152393 · Varian Medical Systems, Inc. · Sep 2015
syngo VSim
K151887 · Siemens Medical Solutions USA, Inc. · Sep 2015
syngo.via RT Image Suite
K151380 · Siemens Medical Solutions USA, Inc. · Aug 2015