Cleared Traditional

K884323 - XIMAVIEW(TM)

K884323 is an FDA 510(k) clearance for XIMAVIEW(TM), manufactured by Varian Assoc., Inc.. The device is a Class 2 Radiology device with product code KPQ cleared through the Traditional 510(k) pathway after a 171-day FDA review.

K884323 · Varian Assoc., Inc. · Radiology device
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Apr 1989
Decision
171d
Days
Class 2
Risk

K884323 is an FDA 510(k) clearance for the XIMAVIEW(TM). 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 April 3, 1989 after a review of 171 days - an extended review 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: 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 - K884323

510(k) Number K884323 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 1988
Decision Date April 03, 1989
Days to Decision 171 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
64d slower than avg
Panel avg: 107d · This submission: 171d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPQ Device Classification - Class 2, Special Controls

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 41
Devices cleared under the same product code (KPQ) and FDA review panel - the closest regulatory comparables to K884323.
AUTOCOMP
K911340 · Victoreen, Inc. · Aug 1991
GE TARGET SERIES 2
K896353 · GE Medical Systems · Dec 1989
SLS SIMULATOR (MODELS SLS-9 AND SLS-14)
K891293 · Philips Medical Systems North America, Inc. · Apr 1989
BEAMSCAN
K853671 · Victoreen, Inc. · Jan 1986
RADIATION BEAM DATA ACQUISTIOIN SYSTEMS
K854880 · Computerized Medical Systems, Inc. · Jan 1986
MEVAPLAN AND SOMADOS
K852410 · Siemens Medical Solutions USA, Inc. · Oct 1985