Cleared Special

K041557 - MOBILEMOSFET WIRELESS DOSIMETRY SYSTEM, MODEL TN-RD-70-W

K041557 is an FDA 510(k) clearance for MOBILEMOSFET WIRELESS DOSIMETRY SYSTEM, manufactured by Thomson & Nielsen Electronics, Ltd.. The device is a Class 2 Radiology device with product code IYE cleared through the Special 510(k) pathway after a 15-day FDA review.

K041557 · Thomson & Nielsen Electronics, Ltd. · Radiology device
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Jun 2004
Decision
15d
Days
Class 2
Risk

K041557 is an FDA 510(k) clearance for the MOBILEMOSFET WIRELESS DOSIMETRY SYSTEM, MODEL TN-RD-70-W. 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 June 25, 2004 after a review of 15 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

FDA 510(k) Submission Details - K041557

510(k) Number K041557 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 2004
Decision Date June 25, 2004
Days to Decision 15 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
92d faster than avg
Panel avg: 107d · This submission: 15d
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

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