DR-ID 1200SDK System— 510(k) K200668

Substantially Equivalent

Fujifilm Corporation

FDA 510(k) clearance K200668 for DR-ID 1200SDK System, Substantially Equivalent on 2020-04-10. Applicant: Fujifilm Corporation. Device class: 2.

Clearance details

Applicant: Fujifilm Corporation
Product code: Code MQB
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 2020-03-13
Decision date: 2020-04-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Ashigara Kami-Gun, JP

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.