Cleared Traditional

K853349 - VARIAN XIMATRON C-SERIES RADIOTHERAPY T...

K853349 is the FDA 510(k) clearance for VARIAN XIMATRON C-SERIES RADIOTHERAPY T... by Varian Assoc., Inc.. It is a Class 2 Radiology device (product code KPQ) cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K853349 · Varian Assoc., Inc. · Radiology device
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Oct 1985
Decision
77d
Days
Class 2
Risk

K853349 is an FDA 510(k) clearance for the VARIAN XIMATRON C-SERIES RADIOTHERAPY TREATMENT ST. Classified as System, Simulation, Radiation Therapy (product code KPQ), Class II - Special Controls.

Submitted by Varian Assoc., Inc. (Palo Alto, US). The FDA issued a Cleared decision on October 28, 1985 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5840 - 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 K853349 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1985
Decision Date October 28, 1985
Days to Decision 77 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 107d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KPQ System, Simulation, Radiation Therapy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5840
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 - KPQ System, Simulation, Radiation Therapy

All 26
Devices cleared under the same product code (KPQ) and FDA review panel - the closest regulatory comparables to K853349.
XIMAVIEW(TM)
K884323 · Varian Assoc., Inc. · Apr 1989
BEAMSCAN
K853671 · Victoreen, Inc. · Jan 1986
MEVAPLAN AND SOMADOS
K852410 · Siemens Medical Solutions USA, Inc. · Oct 1985
THERPAC-RADIATION THERAPY TREATMENT PLANNING SYSTE
K851813 · Victoreen, Inc. · Aug 1985
VARIAN/XIMATRON 5 CARBON-FIBER COUCH TOP
K851653 · Varian Assoc., Inc. · May 1985
XIMATRON V
K810858 · Siemens Corp. · May 1981