Cleared Traditional

K123152 - VITESSE 3.0

K123152 is an FDA 510(k) clearance for VITESSE 3.0, manufactured by Varian Medical Systems, Oncology Systems. The device is a Class 2 Radiology device with product code MUJ cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K123152 · Varian Medical Systems, Oncology Systems · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2012
Decision
59d
Days
Class 2
Risk

K123152 is an FDA 510(k) clearance for the VITESSE 3.0. Classified as System, Planning, Radiation Therapy Treatment (product code MUJ), Class II - Special Controls.

Submitted by Varian Medical Systems, Oncology Systems (Palo Alto, US). The FDA issued a Cleared decision on December 7, 2012 after a review of 59 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.

FDA 510(k) Submission Details - K123152

510(k) Number K123152 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 2012
Decision Date December 07, 2012
Days to Decision 59 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
48d faster than avg
Panel avg: 107d · This submission: 59d
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 256
Devices cleared under the same product code (MUJ) and FDA review panel - the closest regulatory comparables to K123152.
RAYSTATION
K130617 · Raysearch Laboratories AB · May 2013
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K123263 · Eckert & Ziegler Bebig GmbH · Apr 2013
ONQ RTS
K123357 · Oncology Systems, Inc. · Dec 2012
ONCENTRA, ONCENTRA EXTERNAL BEAM, ONCENTRA BRACHY
K121448 · Elekta Inc. D/B/A Nucletron Corporation · Jul 2012
SIMUPLAN TREATMENT PLANNING SYSTEM
K120551 · Simuplan S.L. · Jun 2012
RAYSTATION
K120387 · Raysearch Laboratories AB · Apr 2012
K123152 · VITESSE 3.0
Download PDF FDA Summary Varian Medical System…