dS Base 1.5T; dS Base 3.0T; dS Head 1.5T; dS Head 3.0T; dS HeadNeck 1.5T; dS HeadNeck 3.0T— 510(k) K254190

Substantially Equivalent

Philips Medical Systems Nederland B.V.

FDA 510(k) clearance K254190 for dS Base 1.5T; dS Base 3.0T; dS Head 1.5T; dS Head 3.0T; dS HeadNeck 1.5T; dS HeadNeck 3.0T, Substantially Equivalent on 2026-01-14. 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
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Best, NL
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