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.

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
Combination Product No
PCCP Authorized No
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

All 724
Devices cleared under the same product code (IYE) and FDA review panel - the closest regulatory comparables to K041557.
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K042720 · Varian Medical Systems · Oct 2004
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K041519 · Varian Medical Systems, Inc. · Aug 2004
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CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY
K041315 · Accuray, Inc. · Jun 2004
EXACTRAC 4.0 AND EXACTRAC X-RAY 6D
K040585 · Brainlab AG · May 2004
PROTOS SOFTWARE
K040709 · Aktina Medical Physics Corp. · Apr 2004
K041557 · MOBILEMOSFET WIRELESS DOSIMETRY SYSTEM, MODEL TN-RD-70-W
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