PHILIPS PIXIUM 4343RC— 510(k) K131483

Name: FDA 510(k) clearance K131483
Creator: U.S. Food and Drug Administration
Published: 2013-10-07

Substantially Equivalent

Philips Medical Systems Dmc GmbH

FDA 510(k) clearance K131483 for PHILIPS PIXIUM 4343RC, Substantially Equivalent on 2013-10-07. Applicant: Philips Medical Systems Dmc GmbH. Device class: 2.

Clearance details

Applicant: Philips Medical Systems Dmc GmbH
Product code: Code MQB
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 2013-05-23
Decision date: 2013-10-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seneca, SC, US

Download summary PDF View on FDA.gov ↗

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