KRYSTALRAD NEW SERIESDIGITAL RADIOGRAPHIC PORTABLE RETROFIT SYSTEM— 510(k) K130377

Name: FDA 510(k) clearance K130377
Creator: U.S. Food and Drug Administration
Published: 2013-05-17

Substantially Equivalent

Medicatech USA

FDA 510(k) clearance K130377 for KRYSTALRAD NEW SERIESDIGITAL RADIOGRAPHIC PORTABLE RETROFIT SYSTEM, Substantially Equivalent on 2013-05-17. Applicant: Medicatech USA. Device class: 2.

Clearance details

Applicant: Medicatech USA
Product code: Code MQB
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 2013-02-14
Decision date: 2013-05-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Naples, FL, US

Download summary PDF View on FDA.gov ↗

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