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

Name: FDA 510(k) clearance K262330
Creator: U.S. Food and Drug Administration
Published: 2026-07-30

Substantially Equivalent

Philips 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.

Clearance details

Applicant: Philips Medical Systems Nederland B.V.
Product code: Code MOS
Device class: Class 2
Regulation: 21 CFR 892.1000
Advisory panel: Radiology
Date received: 2026-07-09
Decision date: 2026-07-30
Decision: Substantially Equivalent
Clearance type: Special
Location: Best, NL

Download summary PDF View on FDA.gov ↗

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K260519 — Smart Fit TorsoCardiac 1.5T2026-03-20

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