GAMMALOC SYSTEM, MODEL 03-00001— 510(k) K082588

Name: FDA 510(k) clearance K082588
Creator: U.S. Food and Drug Administration
Published: 2009-12-11

Substantially Equivalent

Dilon Technologies, LLC

FDA 510(k) clearance K082588 for GAMMALOC SYSTEM, MODEL 03-00001, Substantially Equivalent on 2009-12-11. Applicant: Dilon Technologies, LLC. Device class: 1.

Clearance details

Applicant: Dilon Technologies, LLC
Product code: Code IYX
Device class: Class 1
Regulation: 21 CFR 892.1100
Advisory panel: Radiology
Date received: 2008-09-08
Decision date: 2009-12-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newport News, VA, US

Download summary PDF View on FDA.gov ↗

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