Sirius MRI Marker NS— 510(k) K171487

Substantially Equivalent

C4 Imaging, LLC

FDA 510(k) clearance K171487 for Sirius MRI Marker NS, Substantially Equivalent on 2017-08-25. Applicant: C4 Imaging, LLC. Device class: 2.

Clearance details

Applicant: C4 Imaging, LLC
Product code: Code KXK
Device class: Class 2
Regulation: 21 CFR 892.5730
Advisory panel: Radiology
Date received: 2017-05-22
Decision date: 2017-08-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Doylestown, PA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.