Lesion-Loc Iodine I-125 Seed/Needle— 510(k) K142668

Name: FDA 510(k) clearance K142668
Creator: U.S. Food and Drug Administration
Published: 2014-11-21

Substantially Equivalent

Intramedical Imaging, LLC

FDA 510(k) clearance K142668 for Lesion-Loc Iodine I-125 Seed/Needle, Substantially Equivalent on 2014-11-21. Applicant: Intramedical Imaging, LLC. Device class: 2.

Clearance details

Applicant: Intramedical Imaging, LLC
Product code: Code KXK
Device class: Class 2
Regulation: 21 CFR 892.5730
Advisory panel: Radiology
Date received: 2014-09-19
Decision date: 2014-11-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hawthorne, CA, US

Download summary PDF View on FDA.gov ↗

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