Cleared Traditional

K863705 - COMPUTER CONTROLLED EXTENSION (CCX)

K863705 is an FDA 510(k) clearance for COMPUTER CONTROLLED EXTENSION (CCX), manufactured by Varian Assoc., Inc.. The device is a Class 2 Radiology device with product code IYE cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K863705 · Varian Assoc., Inc. · Radiology device
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Jan 1987
Decision
105d
Days
Class 2
Risk

K863705 is an FDA 510(k) clearance for the COMPUTER CONTROLLED EXTENSION (CCX). 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 January 6, 1987 after a review of 105 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Varian Assoc., Inc. devices

FDA 510(k) Submission Details - K863705

510(k) Number K863705 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 1986
Decision Date January 06, 1987
Days to Decision 105 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
2d faster than avg
Panel avg: 107d · This submission: 105d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IYE Device Classification - Class 2, Special Controls

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 561
Devices cleared under the same product code (IYE) and FDA review panel - the closest regulatory comparables to K863705.
VARIAN CLINAC 1800S
K882326 · Varian Assoc., Inc. · Sep 1988
SL SERIES, SL 15, 18, 20 & 25
K874558 · Philips Medical Systems, Inc. · May 1988
GRATICULE
K871214 · Mick Radio-Nuclear Instruments, Inc. · May 1987
CLINAC (R) C SERIES (400C, 600C, 2100C, 2500C)
K862645 · Varian Assoc., Inc. · Oct 1986
VARIAN RMS-2000
K863358 · Varian Assoc., Inc. · Sep 1986
ADAC MODELS XL-PLAN 23 & XL-PLAN 73
K851041 · Adac Laboratories · Jul 1985