Cleared Special

K001833 - PREFERENCE TREATMENT SYSTEM

K001833 is an FDA 510(k) clearance for PREFERENCE TREATMENT SYSTEM, manufactured by Northwest Medical Physics Equipment, Inc.. The device is a Class 2 Radiology device with product code IYE cleared through the Special 510(k) pathway after a 104-day FDA review.

K001833 · Northwest Medical Physics Equipment, Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2000
Decision
104d
Days
Class 2
Risk

K001833 is an FDA 510(k) clearance for the PREFERENCE TREATMENT SYSTEM. Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by Northwest Medical Physics Equipment, Inc. (Lynnwood, US). The FDA issued a Cleared decision on September 28, 2000 after a review of 104 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K001833

510(k) Number K001833 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 2000
Decision Date September 28, 2000
Days to Decision 104 days
Submission Type Special
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
3d faster than avg
Panel avg: 107d · This submission: 104d
Pathway characteristics
Modification to existing cleared device.

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 703
Devices cleared under the same product code (IYE) and FDA review panel - the closest regulatory comparables to K001833.
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K000209 · Scanditronix Wellhofer North America · Aug 2000
K001833 · PREFERENCE TREATMENT SYSTEM
Download PDF FDA Summary Northwest Medical Phy…