I-125 RSLN [RADIOACTIVE SEED AND LOCALIZATION NEEDLE]— 510(k) K141701

Name: FDA 510(k) clearance K141701
Creator: U.S. Food and Drug Administration
Published: 2014-12-05

Substantially Equivalent

Isoaid, LLC

FDA 510(k) clearance K141701 for I-125 RSLN [RADIOACTIVE SEED AND LOCALIZATION NEEDLE], Substantially Equivalent on 2014-12-05. Applicant: Isoaid, LLC. Device class: 2.

Clearance details

Applicant: Isoaid, LLC
Product code: Code KXK
Device class: Class 2
Regulation: 21 CFR 892.5730
Advisory panel: Radiology
Date received: 2014-06-24
Decision date: 2014-12-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Port Richey, FL, US

Download summary PDF View on FDA.gov ↗

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