QLAB Advanced Quantification Software— 510(k) K191647

Name: FDA 510(k) clearance K191647
Creator: U.S. Food and Drug Administration
Published: 2019-12-20

Substantially Equivalent

Philips Health Care

FDA 510(k) clearance K191647 for QLAB Advanced Quantification Software, Substantially Equivalent on 2019-12-20. Applicant: Philips Health Care. Device class: 2.

Clearance details

Applicant: Philips Health Care
Product code: Code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2019-06-20
Decision date: 2019-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bothell, WA, US

Download summary PDF View on FDA.gov ↗

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