Cleared Traditional

K000922 - PROTON VISION

K000922 is the FDA 510(k) clearance for PROTON VISION by Varian Assoc., Inc.. It is a Class 2 Radiology device (product code MUJ) cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K000922 · Varian Assoc., Inc. · Radiology device
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Optimized for regulatory review, auditing and printing
May 2000
Decision
63d
Days
Class 2
Risk

K000922 is an FDA 510(k) clearance for the PROTON VISION. Classified as System, Planning, Radiation Therapy Treatment (product code MUJ), Class II - Special Controls.

Submitted by Varian Assoc., Inc. (Palo Alto, US). The FDA issued a Cleared decision on May 24, 2000 after a review of 63 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 Varian Assoc., Inc. devices

Submission Details

510(k) Number K000922 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 2000
Decision Date May 24, 2000
Days to Decision 63 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
44d faster than avg
Panel avg: 107d · This submission: 63d
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 K000922.
PROTON VISION 7.0
K002312 · Varian Medical Systems, Inc. · Aug 2000
BRAINSCAN
K994413 · Brainlab AG · Jul 2000
XPLAN 2.1
K001700 · Radionics, Inc. · Jun 2000
ADAC PINNACLE3TM RADIATION THERAPY PLANNING SYSTEM
K993923 · Adac Laboratories · Apr 2000
BRACHYVISION 6.0
K992762 · Varian Assoc., Inc. · Mar 2000
CADPLAN PLUS: 3D TREATMENT PLANNING SYSTEM
K992753 · Varian Assoc., Inc. · Sep 1999