Cleared Traditional

K862645 - CLINAC C SERIES (400C

K862645 is the FDA 510(k) clearance for CLINAC C SERIES (400C by Varian Assoc., Inc.. It is a Class 2 Radiology device (product code IYE) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K862645 · Varian Assoc., Inc. · Radiology device
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Oct 1986
Decision
84d
Days
Class 2
Risk

K862645 is an FDA 510(k) clearance for the CLINAC (R) C SERIES (400C, 600C, 2100C, 2500C). Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by Varian Assoc., Inc. (Palo Alto, US). The FDA issued a Cleared decision on October 3, 1986 after a review of 84 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 K862645 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 1986
Decision Date October 03, 1986
Days to Decision 84 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
23d faster than avg
Panel avg: 107d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IYE Accelerator, Linear, Medical
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 - IYE Accelerator, Linear, Medical

All 317
Devices cleared under the same product code (IYE) and FDA review panel - the closest regulatory comparables to K862645.
SL SERIES, SL 15, 18, 20 & 25
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GRATICULE
K871214 · Mick Radio-Nuclear Instruments, Inc. · May 1987
COMPUTER CONTROLLED EXTENSION (CCX)
K863705 · Varian Assoc., Inc. · Jan 1987
VARIAN RMS-2000
K863358 · Varian Assoc., Inc. · Sep 1986
ADAC MODELS XL-PLAN 23 & XL-PLAN 73
K851041 · Adac Laboratories · Jul 1985
LINEAR ACCELERATOR MULTIPLE EXL 3-4-6
K840136 · Adac Laboratories · Mar 1984