Cleared Traditional

K964972 - SHADOWFORM

K964972 is an FDA 510(k) clearance for SHADOWFORM, manufactured by I.Z.I. Medical Products Corp.. The device is a Class 2 Radiology device with product code KPQ cleared through the Traditional 510(k) pathway after a 144-day FDA review.

K964972 · I.Z.I. Medical Products Corp. · Radiology device
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May 1997
Decision
144d
Days
Class 2
Risk

K964972 is an FDA 510(k) clearance for the SHADOWFORM. Classified as System, Simulation, Radiation Therapy (product code KPQ), Class II - Special Controls.

Submitted by I.Z.I. Medical Products Corp. (Owings Mills, US). The FDA issued a Cleared decision on May 5, 1997 after a review of 144 days - within the typical 510(k) review window.

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 I.Z.I. Medical Products Corp. devices

FDA 510(k) Submission Details - K964972

510(k) Number K964972 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 1996
Decision Date May 05, 1997
Days to Decision 144 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d slower than avg
Panel avg: 107d · This submission: 144d
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 35
Devices cleared under the same product code (KPQ) and FDA review panel - the closest regulatory comparables to K964972.
SOMAVISION
K992751 · Varian Assoc., Inc. · Feb 2000
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K973848 · Nucletron Corp. · Jan 1998
VARIAN RADIATION THERAPY IMAGING SYSTEM
K971839 · Varian Medical Systems, Inc. · Aug 1997
VARIAN XIMATRON C-SERIES RADIATION THERAPY SIMULATOR WITH VERSION 4.2 SOFTWARE
K964138 · Varian Medical Systems, Inc. · Jan 1997
SIMVIEW 3000 CT OPTION
K953233 · Siemens Medical Solutions USA, Inc. · Nov 1996
ADVANTAGE SIM
K951830 · General Electric Co. · Nov 1995