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FDA 510(k)

FDR Cross (DR-XD 3000)

K-Number: K212956 · 2021-11-08

ApplicantFujifilm Corporation
Decision Date2021-11-08
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

FDR Cross (DR-XD 3000) is the device name listed in this FDA 510(k) record. The listed applicant is Fujifilm Corporation. It received FDA 510(k) clearance on 2021-11-08 under 510(k) number K212956. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FDR Cross (DR-XD 3000)?

FDR Cross (DR-XD 3000) is a medical device that received FDA 510(k) clearance on 2021-11-08. The listed applicant is Fujifilm Corporation. The 510(k) number is K212956.

When did FDR Cross (DR-XD 3000) receive FDA 510(k) clearance?

FDR Cross (DR-XD 3000) received FDA 510(k) clearance on 2021-11-08, under 510(k) number K212956.

Who is the listed applicant for FDR Cross (DR-XD 3000)?

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 FDR Cross (DR-XD 3000)?

The FDA product code for FDR Cross (DR-XD 3000) is OWB.

Other records listing Fujifilm Corporation as applicant

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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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