dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS Breast Coil 7ch 1.5TdS Sentinelle Breast 16ch 1.5TdS Sentinelle Breast 16ch 3.0T— 510(k) K262330
Substantially EquivalentPhilips Medical Systems Nederland B.V.
FDA 510(k) clearance K262330 for dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS Breast Coil 7ch 1.5TdS Sentinelle Breast 16ch 1.5TdS Sentinelle Breast 16ch 3.0T, Substantially Equivalent on 2026-07-30. Applicant: Philips Medical Systems Nederland B.V.. Device class: 2.
Summary
Philips Medical Systems Nederland's clearance is filed under MOS, specialty magnetic resonance coils. The device name field runs seven coil names together without separators, from dS Breast 7ch 1.5T through dS Sentinelle Breast 16ch 3.0T, with 7ch and 16ch versions labeled 1.5T and 3.0T.
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 21 calendar days (July 9 to July 30, 2026).
Clearance details
- 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
Recent devices under product code MOS
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