Philips Medical Systems Nederland B.V. - FDA 510(k) Cleared Devices
Recent clearances: 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, dS FootAnkle 16Ch 1.5T, Multimodality Simulation Workspace (MM Sim) (v1.0.0)
106
Total
105
Cleared
1
Denied
FDA 510(k) Regulatory Record - Philips Medical Systems Nederland B.V. Pathology ✕
8 devices
Cleared
Mar 06, 2025
Philips IntelliSite Pathology Solution 5.1
Pathology
79d
Cleared
Dec 10, 2024
Philips IntelliSite Pathology Solution 5.1
Pathology
81d
Cleared
Dec 02, 2024
Philips IntelliSite Pathology Solution
Pathology
158d
Cleared
Jun 24, 2024
Philips IntelliSite Pathology Solution 5.1
Pathology
270d
Cleared
Sep 17, 2021
Philips IntelliSite Pathology Solution
Pathology
260d
Cleared
Oct 04, 2017
Philips IntelliSite Pathology Solution
Pathology
77d
Not Cleared
Apr 12, 2017
Philips IntelliSite Pathology Solution
Pathology
132d
Cleared
Sep 19, 2013
PHILIPS HERCEPTEST DIGITAL SCORE
Pathology
259d