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FDA 510(k)

DR-ID 1200SDK System

K-Number: K200668 · 2020-04-10

ApplicantFujifilm Corporation
Decision Date2020-04-10
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DR-ID 1200SDK System is the device name listed in this FDA 510(k) record. The listed applicant is Fujifilm Corporation. It received FDA 510(k) clearance on 2020-04-10 under 510(k) number K200668. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DR-ID 1200SDK System?

DR-ID 1200SDK System is a medical device that received FDA 510(k) clearance on 2020-04-10. The listed applicant is Fujifilm Corporation. The 510(k) number is K200668.

When did DR-ID 1200SDK System receive FDA 510(k) clearance?

DR-ID 1200SDK System received FDA 510(k) clearance on 2020-04-10, under 510(k) number K200668.

Who is the listed applicant for DR-ID 1200SDK System?

The FDA 510(k) record lists Fujifilm Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DR-ID 1200SDK System?

The FDA product code for DR-ID 1200SDK System is MQB.

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Related Devices (Code: MQB)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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