FDA 510(k)

FDR Cross (DR-XD 3000)

K-Number: K212956 · 2021-11-08

Decision Date2021-11-08

Product CodeOWB

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

FDR Cross (DR-XD 3000) is a medical device manufactured by Fujifilm Corporation. It received FDA 510(k) clearance on 2021-11-08 under approval 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. It is manufactured by Fujifilm Corporation. The 510(k) number is K212956.

When was FDR Cross (DR-XD 3000) approved by the FDA?

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

What company makes FDR Cross (DR-XD 3000)?

FDR Cross (DR-XD 3000) is manufactured by Fujifilm Corporation.

What is the FDA product code for FDR Cross (DR-XD 3000)?

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

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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.