Cleared Special

K243033 - dS Wrist coil 8ch 1.5T

K243033 is the FDA 510(k) clearance for dS Wrist coil 8ch 1.5T by Philips Medical Systems Nederland B.V.. It is a Class 2 Radiology device (product code MOS) cleared through the Special 510(k) pathway after a 21-day FDA review.

K243033 · Philips Medical Systems Nederland B.V. · Radiology device
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Oct 2024
Decision
21d
Days
Class 2
Risk

K243033 is an FDA 510(k) clearance for the dS Wrist coil 8ch 1.5T. Classified as Coil, Magnetic Resonance, Specialty (product code MOS), Class II - Special Controls.

Submitted by Philips Medical Systems Nederland B.V. (Best, NL). The FDA issued a Cleared decision on October 18, 2024 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1000 - 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 Philips Medical Systems Nederland B.V. devices

Submission Details

510(k) Number K243033 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2024
Decision Date October 18, 2024
Days to Decision 21 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
86d faster than avg
Panel avg: 107d · This submission: 21d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code MOS Coil, Magnetic Resonance, Specialty
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1000
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 - MOS Coil, Magnetic Resonance, Specialty

All 298
Devices cleared under the same product code (MOS) and FDA review panel - the closest regulatory comparables to K243033.
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