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K232420

Zenition 30

510(k) number
K232420
Device name
Zenition 30
Applicant
Philips Medical Systems Nederland B.V. NL
Product code
OWB — Interventional Fluoroscopic X-Ray System
Decision date
2024-02-16
Date received
2023-08-11
Decision
Substantially Equivalent
Clearance type
Abbreviated
Advisory committee
Radiology
510(k) Summary (official FDA PDF): K232420.pdf
Official FDA record: K232420
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.