COMPUTED RADIOGRAPHY SCANNER— 510(k) K133120

Substantially Equivalent

3Disc Americas

FDA 510(k) clearance K133120 for COMPUTED RADIOGRAPHY SCANNER, Substantially Equivalent on 2014-01-15. Applicant: 3Disc Americas. Device class: 2.

Clearance details

Applicant: 3Disc Americas
Product code: Code MQB
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 2013-09-30
Decision date: 2014-01-15
Decision: Substantially Equivalent
Clearance type: Special
Location: Naples, FL, 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.