KRYSTALRAD 660 DIGITAL RADIOGRAPHIC PORTABLE RETROFIT SYSTEM— 510(k) K112132

Name: FDA 510(k) clearance K112132
Creator: U.S. Food and Drug Administration
Published: 2011-11-18

Substantially Equivalent

Medicatech USA

FDA 510(k) clearance K112132 for KRYSTALRAD 660 DIGITAL RADIOGRAPHIC PORTABLE RETROFIT SYSTEM, Substantially Equivalent on 2011-11-18. 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: 2011-07-26
Decision date: 2011-11-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Naples, FL, US

Download summary PDF View on FDA.gov ↗

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