MRI MARKER— 510(k) K131689

Substantially Equivalent

C4 Imaging, LLC

FDA 510(k) clearance K131689 for MRI MARKER, Substantially Equivalent on 2013-11-20. 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: 2013-06-10
Decision date: 2013-11-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bloomfield Hills, MI, 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.