Cleared Special

MOSFET AUTOSENSE WIRELESS (K032725) - FDA 510(k) Clearance

Class II Radiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K032725 · Thomson & Nielsen Electronics, Ltd. · Radiology device
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Oct 2003
Decision
30d
Days
Class 2
Risk

K032725 is an FDA 510(k) clearance for the MOSFET AUTOSENSE WIRELESS. Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by Thomson & Nielsen Electronics, Ltd. (Ottawa, Ontario, CA). The FDA issued a Cleared decision on October 3, 2003 after a review of 30 days - a notably fast clearance cycle.

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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Thomson & Nielsen Electronics, Ltd. devices

Submission Details

510(k) Number K032725 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 2003
Decision Date October 03, 2003
Days to Decision 30 days
Submission Type Special
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 107d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 204
Devices cleared under the same product code (IYE) and FDA review panel - the closest regulatory comparables to K032725.
MODIFICATION TO: ON-BOARD IMAGER DEVICE
K041519 · Varian Medical Systems, Inc. · Aug 2004
ON-BOARD IMAGER DEVICE
K040192 · Varian Medical Systems, Inc. · Feb 2004
TRILOGY RADIOTHERAPY DELIVERY SYSTEM
K033343 · Varian Medical Systems, Inc. · Dec 2003
ONCOR AVANT-GARDE WITH COHERENCE WORKSPACES
K031764 · Siemens Medical Solutions USA, Inc. · Sep 2003
ECLIPSE 6.5
K010975 · Varian Medical Systems, Inc. · May 2001
PORTALVISION
K003636 · Varian Medical Systems, Inc. · Feb 2001