PORTABLE X-RAY SYSTEM (MODEL:EXARO,XRAY2GO)— 510(k) K141497

Name: FDA 510(k) clearance K141497
Creator: U.S. Food and Drug Administration
Published: 2014-08-26

Substantially Equivalent

Osstem Implant Co., Ltd.

FDA 510(k) clearance K141497 for PORTABLE X-RAY SYSTEM (MODEL:EXARO,XRAY2GO), Substantially Equivalent on 2014-08-26. Applicant: Osstem Implant Co., Ltd.. Device class: 2.

Clearance details

Applicant: Osstem Implant Co., Ltd.
Product code: Code EHD
Device class: Class 2
Regulation: 21 CFR 872.1800
Advisory panel: Dental
Date received: 2014-06-06
Decision date: 2014-08-26
Decision: Substantially Equivalent
Clearance type: Special
Location: Fariless Hills, PA, US

Download summary PDF View on FDA.gov ↗

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