FAXITRON SPECIEN RADIOGRAPHY SYSTEM— 510(k) K122428

Name: FDA 510(k) clearance K122428
Creator: U.S. Food and Drug Administration
Published: 2012-09-25

Substantially Equivalent

Faxitron Bioptics, LLC

FDA 510(k) clearance K122428 for FAXITRON SPECIEN RADIOGRAPHY SYSTEM, Substantially Equivalent on 2012-09-25. Applicant: Faxitron Bioptics, LLC. Device class: 2.

Clearance details

Applicant: Faxitron Bioptics, LLC
Product code: Code MWP
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 2012-08-09
Decision date: 2012-09-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tucson, AZ, 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.