Cleared Traditional

K992751 - SOMAVISION

K992751 is an FDA 510(k) clearance for SOMAVISION, 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 184-day FDA review.

K992751 · Varian Assoc., Inc. · Radiology device
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Optimized for regulatory review, auditing and printing
Feb 2000
Decision
184d
Days
Class 2
Risk

K992751 is an FDA 510(k) clearance for the SOMAVISION. 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 February 16, 2000 after a review of 184 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 - K992751

510(k) Number K992751 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 1999
Decision Date February 16, 2000
Days to Decision 184 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
77d slower than avg
Panel avg: 107d · This submission: 184d
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 K992751.
SIMULIX EVOLUTION
K033470 · Nucletron Corporation · Feb 2004
ACUITY WITH CONEBEAM COMPUTED TOMOGRAPHY
K033339 · Varian Medical Systems, Inc. · Dec 2003
ACUITY RADIATION THERAPY SIMULATOR
K023052 · Varian Medical Systems, Inc. · Oct 2002
HELAX-IMCON, VERSION 1.0
K982857 · Helax AB · Nov 1998
IBU, INTEGRATED BRACHY THERAPY UNIT
K973848 · Nucletron Corp. · Jan 1998
VARIAN RADIATION THERAPY IMAGING SYSTEM
K971839 · Varian Medical Systems, Inc. · Aug 1997