dS FootAnkle 16Ch 1.5T +5 more— 510(k) K262294
Substantially EquivalentPhilips Medical Systems Nederland B.V.
FDA 510(k) clearance K262294 for dS FootAnkle 16Ch 1.5T +5 more, Substantially Equivalent on 2026-07-24. Applicant: Philips Medical Systems Nederland B.V.. Device class: 2.
Summary
Philips Medical Systems Nederland's clearance covers six 16Ch MR coils filed under MOS, specialty magnetic resonance coils: dS FootAnkle, dS HiRes Hand/Wrist, and dS Small Extremity, each in 1.5T and 3.0T versions.
Class II, 21 CFR 892.1000. Radiology is both the classification panel and the review panel, and it came in as a Special 510(k).
Philips filed from Best, Netherlands. Review took 17 calendar days (July 7 to July 24, 2026).
Clearance details
- Device name as filed
- dS FootAnkle 16Ch 1.5T;dS FootAnkle 16Ch 3.0T;dS HiRes Hand/Wrist 16Ch 1.5T;dS HiRes Hand/Wrist 16CH 3.0T;dS Small Extremity 16Ch 1.5T;dS Small Extremity 16Ch 3.0T
- Applicant
- Philips Medical Systems Nederland B.V.
- Product code
- Product code MOS
- Device class
- Class 2
- Regulation
- 21 CFR 892.1000
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Best, NL
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More clearances from Philips Medical Systems Nederland B.V.
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